BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    6507 POWER PRO 2, HIGH CONFIG

    MDR report key: 22608292 · Received July 25, 2025

    Report

    Report Number
    0001831750-2025-99214
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Report Date
    October 1, 2025
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 4 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. 1 DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE THAT WAS PENDING EVALUATION WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. EVALUATION RESULTS FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: FRACTURE PROBLEM/CABLE, MECHANICAL/STRUCTURAL.

    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 SHARP METAL EDGES FOR OUR COT LINES (PRODUCT CODE FPO), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES IN AT LEAST TWO YEARS. THE LAST SERIOUS ADVERSE EVENT MANUFACTURER REPORT #0001831750-2022-00902 WAS ORIGINALLY SUBMITTED ON AUGUST 11TH, 2022. 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    NO NEW INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939431 6507 POWER PRO 2, HIGH CONFIG STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown