BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M1 AMBULANCE COT

    MDR report key: 1972521 · Received December 30, 2010

    Report

    Report Number
    1831750-2010-05439
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RUBBER COATING ON HEAD END EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RUBBER COATING AT THE BAG FOR THE HEAD END EXTENSION HAS LOOSENED. IT IS FURTHER REPORTED THAT THEREFORE, A DISINFECTION CANNOT TAKE PLACE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M1 AMBULANCE COT STRETCHER, WHEELED FPO STRYKER CORP., MEDICAL DIV. 6100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1