BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOF CARE INFLATOR ASSY

    MDR report key: 2140751 · Received June 15, 2011

    Report

    Report Number
    1313850-2011-00146
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE UNIT IS BEING SCRAPPED. A SMALL PUFF OF SMOKE WAS OBSERVED WHEN THE RETURNED UNIT WAS OPERATED AND A SLIGHT ELECTRICAL BURNING SMELL WAS DETECTED. HOWEVER, NO UNUSUALLY HOT AIR TEMPERATURE OR SURFACE TEMPERATURE WAS FOUND. NO VISUAL EVIDENCE OF BURNING WAS FOUND INSIDE THE INFLATOR. A FAILING MOTOR WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS OVERHEATING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF CARE INFLATOR ASSY INFLATOR INX STRYKER CORP DBA GAYMAR SC505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1