Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Product

The FDA is aware that KayserBetten has issued a letter to affected customers recommending all KayserBett IDA pediatric care beds be corrected prior to continued use.

Affected devices: 

• Product Name: KayserBett IDA

What to Do

Follow the provided interim safety measures until the hand control on affected beds can be replaced.

On April 2, KayserBetten sent all affected customers a letter recommending the following actions:

• Be aware that KayserBetten is replacing the hand control on all affected KayserBett IDA beds in the field in the U.S. with a modified hand control featuring an automatic locking function. The adjustment functions on the new hand control will lock automatically after each use.
• Until the hand control replacement has been completed on your bed, strictly observe the following safety measures:
  • If the patient is unattended, take the following actions:  
    • Lower the sleeping platform to its lowest position  
    • Lock the adjustment functions on the hand control using a key  
    • Close the doors
• Ensure all users of the affected device in your facility are aware of this issue.

Reason for Correction

KayserBetten stated that the KayserBett IDA model marketed in the U.S. has a similar risk of injury as a model sold outside the U.S. that was involved in a serious incident that resulted in the death of a child.  

The User Manual instructs users to lock the adjustment function of the hand control with the provided key when the patient (child) is unattended. If the adjustment functions of the hand control are not locked with the provided key when the patient is unattended, there is an increased risk that the patient or other children will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or death.

KayserBetten is replacing the hand control on all affected KayserBett IDA beds in the field in the U.S. with a modified hand control featuring an automatic locking function. The adjustment functions on the new hand control will lock automatically after each use. The hand control replacement will be performed by an authorized service technician at no cost to the customer. The U.S. distributor, Mobility Unlimited Inc. (KayserBetten US), will contact customers to schedule the replacement.

As of April 22, KayserBetten has reported no serious injuries or deaths associated with this issue.

Device Use

The KayserBett IDA is a pediatric care bed intended to provide a safe sleeping and care environment for children with disabilities or chronic health conditions in home-care and institutional settings. The bed features adjustable sleeping platform height and inclination, lockable side enclosures, and a user-operated hand control for adjustment functions.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact KayserBetten at luebben@kayserbetten.de.

Additional FDA Resources  

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.