BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 2830351 · Received October 10, 2012

    Report

    Report Number
    1831750-2012-10583
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASE CROSS-TUBE DETACHED, HEAD SECTION MOUNTING SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BASE CROSS-TUBE WAS DETACHED FROM THE SENSOR HOUSINGS, WHICH WOULD RESULT IN THE COT BEING UNSTABLE. IN ADDITION, THE HEAD SECTION MOUNTING SCREWS WERE STRIPPED, WHICH COULD POTENTIALLY RESULT IN THE HEAD SECTION NO LONGER BEING SECURELY ATTACHED TO THE COT FRAME. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1