BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES PATIENT REPOSITIONER

    MDR report key: 20722793 · Received November 19, 2024

    Report

    Report Number
    20722793
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    August 3, 2024
    Report Date
    November 15, 2024
    Manufacturer
    THE MOREL COMPANY
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT ADMITTED TO AN ACUTE SURGICAL INPATIENT UNIT WAS FOUND UNRESPONSIVE BY PHYSICIAN, COLD TO TOUCH. A CODE BLUE RESUSCITATION RESPONSE WAS ACTIVATED DURING WHICH AN ATTEMPT TO PULL THE CARDIOPULMONARY RESUSCITATION (CPR) LEVER ON A HILL-ROM BED EQUIPPED WITH A HERCULES BED REPOSITIONER FAILED TO LAY THE BED FLAT (UNABLE TO LOWER BELOW 20 DEGREES). THIS WAS REPORTED TO HAVE POSSIBLY IMPACTED THE ABILITY TO ACTIVATE THE CPR MODE ON THE BED. ¿EXCESSIVE TIME OFF CHEST¿ WAS REPORTED AND INTERMITTENT COMPRESSIONS WERE CORRELATED TO THE PLACEMENT OF THE LUCAS DEVICE, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITH MANUAL COMPRESSION. DESPITE RESUSCITATION EFFORTS, THE PATIENT EXPIRED. MANUFACTURER RESPONSE FOR PATIENT TRANSFER AID, PATIENT REPOSITIONER (PER SITE REPORTER). MODIFY MATTRESSES (CUT OUT FOAM) TO ALLOW DEVICE TO LAY FLAT ON TOP OF MATTRESS OR MOVE PATIENT TO FLOOR FOR CPR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44090 HERCULES PATIENT REPOSITIONER BED, AC-POWERED ADJUSTABLE HOSPITAL FNL THE MOREL COMPANY DFSA3N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male