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  5. Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure
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Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure

This recall involves updating instructions for using 731 Ventilator 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 following the updated instructions.

Affected Product

Zoll 731 Ventilator
  • Product Names: MRI Compatible 731 ZOLL Ventilators
  • Model: AEV, EMV+ and Eagle II
  • Lot/Serial Numbers:
    • Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev D)
    • Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev E)
    • Operator’s Guide, Eagle II/AEV (9650-002365-01 Rev B)
    • Quick Reference Guide Eagle 2, EMV+, AEV (9652-000499-01, Rev B)
    • Quick Reference Guide (9652-000511-01 Rev A)
    • Operator’s Guide (906-0731-01 Rev L)
    • Quick Reference Guide (907-0731-04 Rev B)

What to Do

On June 12, 2024, ZOLL sent all affected customers an Urgent Corrective Action notice recommending the following actions: 

  • Locate all old versions of affected Operator’s Guides and/or Quick Reference Guides and dispose.
  • Complete and return the attached customer response form via e-mail, fax, or mail to request replacement manuals.
  • Alert all users of the ZOLL Ventilator with MRI Compatibility, to ensure they are aware of the safe distance requirements and are trained to these manual updates. 

Reason for Updates to Use Instructions

ZOLL Medical Corporation is updating use instructions for 731 ventilators due to Magnetic Resonance Imaging (MRI) safety information in the labeling, that may lead to misuse and ventilator failure. The Operator’s Guide and Quick Reference Guide (QRG) include information on how far the ventilator should be placed from the MRI machine based on the magnetic field strength. However, a review found that some important details were accidentally left out of these guides. This missing information might lead users to place the ventilator too close to the MRI machine, which could cause the ventilator to trigger alarms, device malfunction or unexpectedly shut down.

The use of affected product may cause serious adverse health consequences, including lack of oxygen, difficulty breathing, organ damage, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The ZOLL 731 Series Ventilator family includes the AEV, EMV+, and Eagle II models. These are small, sturdy, and fully equipped portable ventilators that help infants (weighing at least 5 kg), children, and adults with breathing. They can be used in hospitals, during transport, and in field hospitals.

These ventilators can run on AC or DC power sources or their built-in battery. They offer various breathing support modes such as Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), and Continuous Positive Airway Pressure (CPAP) with or without PS. They also support both noninvasive and positive pressure ventilation.

Contact Information

Customers in the U.S. with questions about this recall should contact ZOLL technical support at 1-800-348-9011 or 1-978-421-9460.

Additional FDA Resources:

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

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.

 

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