BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER, ELECTRIC

    MDR report key: 2932851 · Received December 28, 2012

    Report

    Report Number
    1831750-2012-13448
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED PCB ASSEMBLY, LOCAL CELL AND COMM CABLE AS PRECAUTIONARY. STRYKER TECHNICIAN COULD NOT DUPLICATE THE EVENT. THE UNIT MET AND PERFORMED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE ZOOM SPEED WAS EXCESSIVELY FAST; HOWEVER, STRYKER TECHNICIAN COULD NOT DUPLICATE THE EVENT. THE UNIT MET AND PERFORMED TO SPECIFICATIONS. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME ZOOM STRETCHER, ELECTRIC POWERED WHEELED STRETCHER FPO STRYKER MEDICAL 1125000000E NA

    Patients

    Seq Age Sex Outcome Treatment
    1