BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME ZOOM STRETCHER30INLITTER

    MDR report key: 7698838 · Received July 18, 2018

    Report

    Report Number
    0001831750-2018-00755
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    March 2, 2018
    Report Date
    September 6, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    UDI-DI
    07613327278293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2014007. THE DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 1

    THE UNITS WERE NOT EVALUATED AS THE CUSTOMER CANCELLED THEIR SERVICE REQUEST AND INDICATED THEY HAD PERFORMED THEIR OWN REPAIRS. CUSTOMER CANCELLED SERVICE REQUEST.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE UNIT WAS NOT PASSING GROUND RESISTANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE UNIT WAS NOT PASSING GROUND RESISTANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541036 PRIME ZOOM STRETCHER30INLITTER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 07613327278293

    Patients

    Seq Age Sex Outcome Treatment
    1