BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER, ELECTRIC

    MDR report key: 12527345 · Received September 24, 2021

    Report

    Report Number
    0001831750-2021-01332
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 30, 2021
    Report Date
    December 3, 2021
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    UDI-DI
    07613327278286
    PMA / PMN Number
    K140095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY INSTALLING NEW ECL CARRIAGE BOLT AND ECL BARREL NUT. CORRECTED DATE OF MANUFACTURE IN SECTION H4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE RIGHT RAIL OF THE BED THERE IS A CIRCLE PART THAT IS BROKEN AND PEOPLE ARE GETTING THEIR FINGERS CAUGHT IN IT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE RIGHT RAIL OF THE BED THERE IS A CIRCLE PART THAT IS BROKEN AND PEOPLE ARE GETTING THEIR FINGERS CAUGHT IN IT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424130 PRIME ZOOM STRETCHER, ELECTRIC STRETCHER, WHEELED POWERED INK STRYKER MEDICAL-KALAMAZOO 1125 07613327278286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown