BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR EXPRESS APM

    MDR report key: 6043771 · Received October 20, 2016

    Report

    Report Number
    0001831750-2016-00328
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    June 10, 2016
    Report Date
    January 5, 2017
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY DISCUSSING THE ISSUE WITH THE ACCOUNT AND CONFIRMING THAT NOTHING FURTHER WAS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER INLET HAD BECOME DETACHED FROM THE UNIT WITH EXPOSED BARE WIRES. ALLEGEDLY A CAREGIVER RECEIVED AN ELECTRICAL SHOCK FROM THE EXPOSED WIRES. HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT WAS AFFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER INLET HAD BECOME DETACHED FROM THE UNIT WITH EXPOSED BARE WIRES. ALLEGEDLY A CAREGIVER RECEIVED AN ELECTRICAL SHOCK FROM THE EXPOSED WIRES. HOWEVER, NO MEDICAL INTERVENTION WAS REPORTED FOR THE SHOCK. NO PATIENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696694 AIR EXPRESS APM BED, FLOTATION THERAPY, POWERED IOQ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1