BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHEEL

    MDR report key: 2935519 · Received January 4, 2013

    Report

    Report Number
    1831750-2013-90057
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OXYGEN BOTTLE. STRYKER TECH EVALUATED THE UNIT AND CONFIRMED THAT THE ALLEGED EVENT WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER WILL NOT PUMP UP FROM THE LOWEST POSITION. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT. STRYKER TECH REVIEWED THE UNIT AND CONFIRMED IT TO BE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5621 SM104 MSERIES W5TH WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1