BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHL

    MDR report key: 2920429 · Received December 7, 2012

    Report

    Report Number
    1831750-2012-12603
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Removal / Correction Number
    Z-226-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRAKE CAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WOULD NOT ENGAGE PROPERLY. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WAS ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 MSERIES W5TH WHL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1