BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 2910173 · Received December 19, 2012

    Report

    Report Number
    1831750-2012-12973
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESTRAINTS. MFR'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFO IS RECEIVED, THEN A F/U WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS STRAPPED TO THE COT AND GOT OUT OF THE STRAPS. THERE WAS PT INVOLVEMENT AND ADVERSE CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1