BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL SOF CARE INFLATOR ASSY

    MDR report key: 3002693 · Received March 13, 2013

    Report

    Report Number
    0001831750-2013-01979
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE AC CORD WAS PULLING FROM THE JACKED AND THE HANDLES WERE BROKEN WITH SHARP EDGES. HOWEVER IT WAS DETERMINED UPON INVESTIGATION THAT THE POWER CORD WAS MISSING. THE POWER CORD MISSING IS AN ANNOYANCE ONLY ISSUE AND WOULD BE APPARENT TO THE CAREGIVER.

    Additional Manufacturer Narrative · 1

    MATTRESS TO BE SCRAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE AC CORD WAS PULLING FROM THE JACKED AND THE HANDLES WERE BROKEN WITH SHARP EDGES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE AC CORD WAS PULLING FROM THE JACKED AND THE HANDLES WERE BROKEN WITH SHARP EDGES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105454 CAPITAL SOF CARE INFLATOR ASSY MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death