BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2949547 · Received January 10, 2013

    Report

    Report Number
    1831750-2013-90326
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE FOOT END JACK COULD NOT BE LOWERED; HOWEVER, STRYKER TECHNICIAN COULD NOT DUPLICATE THE EVENT. THE UNIT MET AND PERFORMED TO SPECIFICATIONS. CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16131 SM204 M-SERIES W/BIG WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1