BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ZOOM STRETCHER, PRIME X

    MDR report key: 10001500 · Received April 27, 2020

    Report

    Report Number
    0001831750-2020-00442
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    January 1, 2020
    Report Date
    July 14, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    UDI-DI
    07613327278323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THERE WAS NO DEFECT WITH THE DEVICE; THE CUSTOMER COULD NOT DUPLICATE THE ISSUE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE ZOOM DISENGAGED DURING USE.  THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE ZOOM DISENGAGED DURING USE.  THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465042 ZOOM STRETCHER, PRIME X STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1125 07613327278323

    Patients

    Seq Age Sex Outcome Treatment
    1