BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED+

    MDR report key: 3133151 · Received May 29, 2013

    Report

    Report Number
    0001831750-2013-04800
    Event Type
    Malfunction
    Date Received
    May 29, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS REPORTED BY CUSTOMER. CONCLUSION: THE UNIT WAS NOT REPAIRED AS IT HAD SINCE BEEN SOLD; HOWEVER, THE NEW OWNER OF THE UNIT WAS MADE AWARE OF THE SCALE ISSUE AND WAS INFORMED TO CONTACT STRYKER MEDICAL TO HAVE THE SCALE REPAIRED AT A FUTURE TIME. EVALUATION PERFORMED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    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
    236495 GOBED+ BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1