BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES PATIENT REPOSITIONER

    MDR report key: 19992706 · Received August 14, 2024

    Report

    Report Number
    MW5158427
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 28, 2024
    Report Date
    August 9, 2024
    Manufacturer
    THE MOREL COMPANY
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN ATTEMPT TO PULL THE CPR LEVER ON A CENTRELLA BED WITH A HERCULES DEVICE INSTALLED ALLEGEDLY FAILED TO LAY THE BED FLAT AND ACTIVATE THE CPR MODE. A SAFETY REPORT INDICATED THAT THE BED WAS FOUND TO BE APPROXIMATELY AT 20 DEGREE ANGLE. THE BED WAS OBSERVED TO BE PLUGGED AND EVEN WITH THE USE OF THE REMOTE TO PLACE THE HEAD OF THE BED DOWN, ALLEGEDLY, IT DID NOT WORK. REPLICATION OF THE EVENT DID NOT DEMONSTRATE THE REPORTED PROBLEM. THE MATTRESS WAS OBSERVED TO BE LAYING ON TOP OF THE HERCULES DEVICE, RENDERING AN INCLINATION OF THE MATTRESS TO ABOUT 10 DEGREE ANGLE FROM BEDFRAME BASELINE. IT IS ALSO NOTED THE WHOLE BEDFRAME WAS IN NEUTRAL POSITION. THE CLAIM IS THAT THE INABILITY OF THE BED TO RECLINE INTERFERED WITH THE INITIATION OF CARDIO-PULMONARY RESUSCITATION. A SIMULATION OF THE EVENT WAS CONDUCTED ON 8/5/24 AND 8/7/24 TO REPLICATE THE ISSUE IDENTIFIED IN THE REPORTED EVENT. BOTH SIMULATIONS DEMONSTRATE THAT THE HERCULES DEVICE INSTALLED ON THE BEDFRAME DID NOT AFFECT THE INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. THE CPR LEVER ON THE CENTRELLA BED ACTIVATED AS SOON AS IT WAS PULLED AND THE HEAD PART OF THE BED/ BEDFRAME RECLINED TO NEUTRAL POSITION (ZERO DEGREE) AND THE MATTRESS WAS NOTED TO BE AT 10 DEGREE INCLINE DUE TO THE HERCULES DEVICE EXPECTED PROTRUSION. THE MATTRESS WAS NOTED TO BE FIRM AND THE INCLINE FROM THE HERCULES DEVICE DID NOT AFFECT INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. WE WERE NOT ABLE TO REPLICATE THE REPORTED 20 DEGREE ANGLE ISSUE OF THE BED. REF REPORT: MW5158426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007027 HERCULES PATIENT REPOSITIONER BED, AC-POWERED ADJUSTABLE HOSPITAL FNL THE MOREL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening