BEUDAMED
    FDA Adverse Event Death Summary report: N

    6506 MTS PWRPRO COT MID CONFIG

    MDR report key: 22077188 · Received May 23, 2025

    Report

    Report Number
    0001831750-2025-00701
    Event Type
    Death
    Date Received
    May 23, 2025
    Date of Event
    March 11, 2025
    Report Date
    October 3, 2025
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THE REPORT, A STRYKER QUALITY ASSURANCE ENGINEER MADE THREE ATTEMPTS TO GET MORE INFORMATION FROM A STRYKER SALES REP. HE STATED THAT THEY ARE UNABLE TO PROVIDE INFORMATION AS THE AMBULANCE IS STILL UNDER POLICE AND DA INVESTIGATION. THROUGH THIS COMMUNICATION, IT WAS DETERMINED THAT THE UNIT WAS NOT MADE AVAILABLE TO EVALUATION AS THE UNIT IS BEING HELD AT THE IMPOUND LOT. BASED ON THE COMMUNICATION WITH THE SALES REPRESENTATIVE AND THE INFORMATION PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ALLEGED PATIENT INJURY WAS LIKELY NOT CAUSED OR CONTRIBUTED BY THE DEVICE, AS NO MALFUNCTION WAS ALLEGED WITH THE DEVICE THAT WAS INVOLVE IN AN AMBULANCE ACCIDENT. HOWEVER, THIS COULD NOT BE CONFIRMED, SINCE THE UNIT WAS NOT AVAILABLE FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER INFORMATION ABOUT THE ACCIDENT, WITH NO RESPONSE RECEIVED. SHOULD A RESPONSE BE RECEIVED, THIS COMPLAINT MAY BE REOPENED AND UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    THERE IS NO NEW INFORMATION TO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS IN AN AMBULANCE ACCIDENT. THE PATIENT INVOLVED PASSED AWAY. NO PRODUCT MALFUNCTION WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515083 6506 MTS PWRPRO COT MID CONFIG STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death