BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN ADVANCE CHEST SUPPORT W/PAD

    MDR report key: 9880976 · Received March 25, 2020

    Report

    Report Number
    3010216206-2020-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Report Date
    February 26, 2020
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    GDC
    UDI-DI
    00615521003159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEN ADVANCE CHEST SUPPORT WITH PAD HAS BEEN REMOVED FROM USE AND WILL BE RETURNED TO ALLEN MEDICAL FOR EVALUATION AND INVESTIGATION. THE INVESTIGATION IS CURRENTLY ONGOING. ALLEN MEDICAL IS UNABLE TO CONFIRM AT THIS TIME IF THE DEVICE MALFUNCTIONED IN A WAY THAT WOULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION UNTIL THE INVESTIGATION IS COMPLETE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILLROM/ALLEN MEDICAL RECEIVED A REPORT FROM THE ACCOUNT STATING THE CHEST SUPPORT BRACKET BROKE CLEAN AWAY AT SITE OF THE RAIL. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345118 ALLEN ADVANCE CHEST SUPPORT W/PAD TABLE, OPERATING-ROOM, ELECTRICAL GDC ALLEN MEDICAL SYSTEMS A-71301 00615521003159

    Patients

    Seq Age Sex Outcome Treatment
    1