BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 2232788 · Received July 19, 2011

    Report

    Report Number
    1831750-2011-07210
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSED SHARP EDGES ON REAR SPINDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE PT LEFT SIDE RAIL LATCH SPINDLE WAS SHEARED OFF AND THERE WERE SHARP EDGES. THE CUSTOMER COULD NOT DETERMINE WHETHER THERE WAS PT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PRO AMBULANCE COT STRETCHER, WHEELED INK STRYKER MEDICAL 6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1