BEUDAMED
    FDA Adverse Event Death Summary report: N

    6507 POWER PRO 2, HIGH CONFIG

    MDR report key: 23881840 · Received December 23, 2025

    Report

    Report Number
    0001831750-2025-00753
    Event Type
    Death
    Date Received
    December 23, 2025
    Date of Event
    November 17, 2025
    Report Date
    May 4, 2026
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327559118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE ALLEGED EVENT, A STRYKER QAE CONTACTED A STRYKER FIELD SERVICE TECHNICIAN AND A STRYKER SALES ACCOUNT MANAGER FOR FURTHER INFORMATION. THE STRYKER FIELD SERVICE TECHNICIAN STATED THAT HE SPOKE TO A MANAGER, A LIEUTENANT, AT THE ACCOUNT THAT CONFIRMED THE AMBULANCE ACCIDENT DID OCCUR AND THE CORONER DID NOT CONDUCT AN AUTOPSY. HE ALSO CONFIRMED THAT THE PATIENT WAS NOT IN GOOD HEALTH PRIOR TO THE ACCIDENT AND HAD AN EXTERNAL PORT OF SOME KIND IN THEIR ABDOMINAL AREA. THIS PORT WAS DISTURBED BY THE FORCE OF THE IMPACT FROM THE ACCIDENT. THE PATIENT WAS TRANSPORTED BY ANOTHER AMBULANCE TO THE HOSPITAL AFTER THE ACCIDENT WHO WAS ALIVE AND STABLE. THE STRYKER SALES ACCOUNT MANAGER RESPONDED, SAYING THE STRYKER FIELD SERVICE TECHNICIAN HAS BEEN THE ONE ON-SITE TO INSPECT THE EQUIPMENT AND HAS MAINTAINED COMMUNICATION WITH THE CUSTOMER. THEREFORE, THE STRYKER SALES ACCOUNT MANAGER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OTHER THAN THE FRAME OF THE COT IS BENT AND COULD HAVE EVEN FURTHER, UNSEEN, STRESSES/DAMAGES EVEN BEYOND WHAT IS VISIBLE. AS A RESULT OF THIS REPORT, A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY THE STRYKER FIELD SERVICE TECHNICIAN. IT WAS FOUND THAT THE ISSUES FOR THE COT INVOLVED IN THE AMBULANCE ACCIDENT WAS NOT DUE TO ANY COMPONENT LEVEL DEFECT WITH THE PRODUCT. BASED ON THE POST-ACCIDENT INSPECTION AND PHOTOS PROVIDED IN THE WORK ORDER, A STRYKER QAE DETERMINED THE UNIT SHOULD BE REMOVED FROM USE (RFU). THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY PERFORMING A POST-ACCIDENT INSPECTION, RECOMMENDING REMOVING THE COT FROM USE (RFU), AND ENSURING NOTHING ELSE WAS NEEDED FROM STRYKER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN AMBULANCE ACCIDENT. THE PATIENT BEING TRANSPORTED PASSED AWAY AS A RESULT OF INJURIES SUSTAINED IN THE CRASH. THE CORONER¿S OFFICE BELIEVES THE COT RESTRAINTS MAY HAVE CONTRIBUTED TO THE PATIENT¿S INJURIES, BUT THIS HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN AMBULANCE ACCIDENT. THE PATIENT BEING TRANSPORTED PASSED AWAY AS A RESULT OF INJURIES SUSTAINED IN THE CRASH. THE CORONER'S OFFICE BELIEVES THE COT RESTRAINTS MAY HAVE CONTRIBUTED TO THE PATIENT¿S INJURIES, BUT THIS HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457815 6507 POWER PRO 2, HIGH CONFIG STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327559118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death