BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PACU DESIGNER MOD. OBS 1/95

    MDR report key: 9638171 · Received January 28, 2020

    Report

    Report Number
    0001831750-2020-00259
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 29, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS NOT MADE AVAILABLE FOR TESTING BY THE CUSTOMER; NO CAUSE WAS ESTABLISHED. 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 BRAKES WERE DIFFICULT TO ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101836 PACU DESIGNER MOD. OBS 1/95 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1