BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED+

    MDR report key: 3130446 · Received May 24, 2013

    Report

    Report Number
    0001831750-2013-04760
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Removal / Correction Number
    RA-2011-070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP BEING SUBMITTED AS THE EVALUATION OF THE PRODUCT HAS BEEN COMPLETED BY THE ACCOUNT. THE REPAIR WAS COMPLETED BY SENDING THE ACCOUNT LOAD CELLS AS THE ACCOUNT WILL COMPLETE THE REPAIR. THE METHOD, RESULTS AND CONCLUSION SECTION HAVE BEEN UPDATED TO REFLECT THE EVALUATION BEING COMPLETED BY THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCALE WAS INACCURATE DUE TO LOAD CELL MALFUNCTION. 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 THE SCALE WAS INACCURATE DUE TO LOAD CELL MALFUNCTION. 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
    231066 GOBED+ BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1