BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT SERIES

    MDR report key: 2073020 · Received April 21, 2011

    Report

    Report Number
    1831750-2011-03919
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METAL TAB BY USING THE REMOVABLE IV POLES FOR STEER, THE TABS TO HOLD THE IV POLES ON THE STRETCHER, WERE BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER HAD TABS ON THE LITTER AT THE HEAD END FOR A REMOVABLE IV POLE. THE TABS HAVE BEEN TORN OFF THE STRETCHER LEAVING SHARP METAL EDGES EXPOSED AND THERE WAS A BROKEN WELD INCHES AWAY FROM THE TABS WHERE THE HEADEND FRAME AND THE SIDE FRAME CONNECT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPORT SERIES HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 0721 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK