BEUDAMED
    FDA Adverse Event Death Summary report: N

    5TH WHEEL STRETCHER, PRIME X

    MDR report key: 13386505 · Received January 28, 2022

    Report

    Report Number
    0001831750-2022-00244
    Event Type
    Death
    Date Received
    January 28, 2022
    Date of Event
    January 26, 2022
    Report Date
    April 29, 2022
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE UNIT INVOLVED IN THE INCIDENT WAS NOT RECORDED. AS A RESULT, THE UNIT COULD NOT BE INSPECTED, HOWEVER, THE CUSTOMER WAS UNABLE TO STATE WHETHER THE ISSUE WAS DUE TO A MALFUNCTION WITH THE DEVICE AND PUT THE UNIT BACK INTO SERVICE. MULTIPLE REQUESTS, INCLUDING WRITTEN, WERE SENT TO THE ACCOUNT FOR ADDITIONAL INFORMATION RELATED TO THE ALLEGED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE ACCOUNT. A REVIEW OF PREVIOUS SIMILAR COMPLAINTS IDENTIFIED THAT THE ISSUE WAS LIKELY NOT DUE TO A DEFECT WITH THE PRODUCT. H3 OTHER TEXT : DEVICE NOT ACCESSIBLE FOR EVALUATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD ALLEGEDLY GOT THERE HEAD BETWEEN THE SIDE-RAILS AND HAS SINCE DIED. THE CUSTOMER HAS NOT STATED IF THE TRAPPING OF THE HEAD WAS DUE TO A MALFUNCTION OF THE SIDE-RAIL AND HAS PUT THE STRETCHER BACK INTO USE. THE CUSTOMER IS ALSO UNABLE TO CONFIRM THE SERIAL NUMBER OF THE STRETCHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD ALLEGEDLY GOT THEIR HEAD BETWEEN THE SIDE-RAILS AND HAS SINCE DIED. THE CUSTOMER HAS NOT STATED IF THE TRAPPING OF THE HEAD WAS DUE TO A MALFUNCTION OF THE SIDE-RAIL AND HAS PUT THE STRETCHER BACK INTO USE. THE CUSTOMER IS ALSO UNABLE TO CONFIRM THE SERIAL NUMBER OF THE STRETCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735950 5TH WHEEL STRETCHER, PRIME X STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death