BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS OBS 10/25/04

    MDR report key: 3162474 · Received June 11, 2013

    Report

    Report Number
    0001831750-2013-05285
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, IT WAS REPORTED THAT THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THIS WAS REPORTED IN ERROR. THE UNIT WAS SCRAPPED BY STRYKER AND A REPLACEMENT UNIT WAS ORDERED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO A BROKEN LATCHING BRACKET WELD, WITH SHARP EDGES EXPOSED. 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 SIDE RAIL COULD NOT REMAIN LATCHED DUE TO A BROKEN LATCHING BRACKET WELD, WITH SHARP EDGES EXPOSED. 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
    263202 ATLAS OBS 10/25/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1