BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BIG WHL STRTCHR, PRIME X,PWRD

    MDR report key: 23393061 · Received October 27, 2025

    Report

    Report Number
    0001831750-2025-99368
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    January 7, 2026
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE THAT WAS PENDING WAS EVALUATED AND IT WAS DETERMINED THE DEVICE EXPERIENCED COSMETIC/AESTHETICS ISSUE, NOT AFFECTING FUNCTION, WHICH IS NOT REPORTABLE. THE NUMBER OF EVENTS SUMMARIZED HAS BEEN CHANGED TO 0, BUT THE FIELD IS MARKED AS 1 DUE TO SYSTEM REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    IN ACCORDANCE WITH THE ¿FINAL GUIDANCE ON MEDICAL DEVICE REPORTING FOR MANUFACTURERS¿ ISSUED ON NOVEMBER 7, 2016, STRYKER MEDICAL WILL NO LONGER REPORT THE HAZARD OF AC SHOCK; ACCESSIBLE (AC) POWER/EXPOSED BARE WIRES FOR OUR STRETCHER LINES (PRODUCT CODE FPO), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES. WHILE NO NEW MDRS WILL BE GENERATED FOR THIS HAZARD MOVING FORWARD, ADDITIONAL SUPPLEMENTAL RECORDS MAY BE SUBMITTED FOR PAST REPORTED EVENTS IF NEW INFORMATION BECOMES AVAILABLE. SHOULD A NEW SERIOUS ADVERSE EVENT OCCUR ATTRIBUTED TO THIS HAZARD, MDR REPORTING WILL RESUME.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE IS PENDING EVALUATION. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS), 1 DEVICE: APPROPRIATE TERM/CODE NOT AVAILABLE / RESULTS PENDING COMPLETION OF INVESTIGATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT NOW SUMMARIZES 0 MALFUNCTION EVENTS(S), INSTEAD OF 1.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2740736 BIG WHL STRTCHR, PRIME X,PWRD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327278255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown