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U.S. Department of Health and Human Services

Medical Devices

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FDA Alert - Pediatric Cribs

This is an archived document and is no longer current information.

 

July 2, 1984

 

Dear Director of Nursing:

Please share this with:

  • Hospital Administrator
  • Chief, Pediatric Services
  • Director, Biomedical Engineering

This is to alert you to a hazard associated with pediatric cribs with security tops, and to suggest precautions you should take to avoid entrapment accidents that could cause death or serious injuries to infants placed in these cribs. Although two specific model cribs have been implicated and several manufactures have taken action, we concerned that some owners may not have received the manufactures’ notification because of traceability problems. It is also possible that other crib makes and models could present a similar hazard.

In the past ten months, two children, ages 17 months and 23 months, were strangled when their heads were caught between the top of the side rail and the lower edge of the security tops. The two fatalities occurred with the Tabbert ”Tab Crib” Pediatric Crib, model C-374, and the Hill-Rom Pediatric Crib, Model 249. Both the Tabbert and the Hill-Rom cribs and tops represent a single basic design (Figure 1). They have been distributed by several companies and under several brand names. These are the label names, which you might find on cribs (the tops have no labels) and the company contacts:

 

Tabbert, or “TAB” Crib

Midmark, Inc., (800) 643-6275

Model C-374


Whittaker Medical Manufacturing Co., (800) 446-3008

Cambridge Scientific Industries, (800) 638-9566

Hill-Rom, Model 249

Hill-Rom Company, Inc., (800) 934-7777


TODAY Crib, Model C-374


InterRoyal Corp., (212) 686-3500

 

In both known cases involving fatalities, the accident occurred because the security top was not properly latched. Improper latching could result from either: (1) lowering the security top AFTER raising the side rail, causing the latching tabs to rest outside the top or the side rail (Figure 2), or (2) raising the side rail, by grasping it towards one end rather than in the middle, causing only that the end to lock into place. This would increase the gap between the bottom edge of the security top and the top of the side rail at the unlocked end (see Figure 3). To properly engage the security top, the security top must be lowered FIRST. Then the side rail must be grasped in the middle and raised, assuring that both ends are locked and that the latching tabs on the security top rest BEHIND the top of the side rail (see Figure 4).

Inadequate latching may also result from improper installation of the security top. When the top is installed, the gap between the bottom edges of the security top and the top edges of both side rails must not exceed one inch (1”). Otherwise the latching tabs may not catch hold behind the side rails. Since the cribs and tops have been produced by several manufactures, the possibility exits that they are not all identical. This may cause excessive gaps if cribs and tops are interchanged. Excessive gaps may also result from damaged (bent), corroded, or dirty security top support posts.

Midmark, on December 16, 1983, initiated corrective action by letter notification and by providing a retrofit kit with larger security top latching tabs, warning decals, and undated instructions. Hill-Rom (May 18, 1984), Cambridge (June 7, 1984), and Whittaker (March 6, 1984) have also initiated this action for their customers. The manufacturers are doing their best to locate all cribs, but we are concerned that surplus cribs may have been sold without transfer records, or that the same or similar cribs may have been sold by other distributors under different brand or model designations.

It is extremely important to take measures to prevent further mishaps in pediatric wards. EVEN WITH THE RETROFIT KIT INSTALLED, IMPROPER OPERATION CAN CREATE THE ENTRAPMENT HAZARD. We suggest the following preventive measures:

If you have any labeled cribs listed on page one, ensure that the retrofit kits (latching tabs and warning decals) are obtained and properly installed, and that the updated instructions for security top installation and use are followed by all hospital personnel who may use these cribs. Please try to work through the manufacturer who provided you the cribs. If there is any question of origin of a Tabbert crib, contact Midmark, the only known current manufacturer and distributor, and the developer of the retrofit kits.

Determine if your hospital has any other cribs with similar features (some cribs may be unlabeled). If so, review the instruction manuals with all affected hospital staff, and attach prominent warning placards to the security tops and /or side rails to remind users of the proper procedure to latch the security top. Please contact Mr. William K. Young of my staff at 301-443-4600 to determine if other measures (e.g., retrofit kits) are necessary and available.

Schedule preventive maintenance for all cribs and security tops of this design, especially for the latching mechanisms of both the side rails and security tops. Make sure the gap between BOTH side rails and the security top does not exceed one inch. Consider labeling the cribs and corresponding tops to avoid future interchanging. If you have trouble achieving the proper gap, contact the appropriate manufacturer(s).

If it is necessary for parents (or other visitors) to operate the crib or security top, make sure they are properly instructed to ensure safe operation.

If you own or are aware of similar cribs and tops from manufacturers not mentioned in this alert, or if you have any other questions, please contact Mr. Young at the phone number above. Reports of entrapment incidents or other crib problems may be directed to : Dr. Joseph G. Valentino, Product Problem Reporting Program, The United States Pharmacopoeia, 12601 Twinbrook Parkway, Rockville, MD 20852, (800-638-6725).

We appreciate your cooperation, and hope this information will help prevent further mishaps.

 

Sincerely yours,

John C. Villforth
Director
Center for Devices and Radiological Health
Food and Drug Administration

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100