BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 26 OBS 10/04

    MDR report key: 2963554 · Received February 15, 2013

    Report

    Report Number
    0001831750-2013-01187
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT CORRECTS THE AWARENESS DATE. PREVIOUSLY, IT WAS REPORTED THAT STRYKER WAS AWARE OF THE ISSUE ON (B)(4) 2013. THIS WAS INCORRECT. STRYKER WAS NOT AWARE OF THE ISSUE UNTIL (B)(4) 2013. THIS IS THE ACTUAL REPORTABLE AWARENESS DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE STRETCHER WAS BROKEN. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKES COULD NOT BE ENGAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE STRETCHER WAS BROKEN. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKES COULD NOT BE ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66682 ADVANTAGE SERIES 26 OBS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1009

    Patients

    Seq Age Sex Outcome Treatment
    1