BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOOR MOUNT FASTENER SNGL PLT

    MDR report key: 3013943 · Received March 20, 2013

    Report

    Report Number
    0001831750-2013-02260
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INCORRECTLY REPORTED THAT THE PRODUCT WAS A MODEL 6500000000, SERIAL NUMBER (B)(4), AMBULANCE COT. THE AMBULANCE COT REPORTED IN THE ORIGINAL REPORT IS ACTUALLY THE CONCOMITANT PRODUCT INVOLVED WITH THIS COMPLAINT. THE ACTUAL PRODUCT THAT IS BEING REPORTED FOR THIS COMPLAINT IS A MODEL 6370 FLOOR MOUNT FASTENER, SERIAL NUMBER UNKNOWN. THERE WAS NO KNOWN DEVICE PROBLEM FOR THE AMBULANCE COT THAT WAS ORIGINALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE RAIL ASSEMBLY WOULD NOT LATCH AUTOMATICALLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE RAIL ASSEMBLY WOULD NOT LATCH AUTOMATICALLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115912 FLOOR MOUNT FASTENER SNGL PLT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 6500000000, POWER PRO AMBULANCE COT