BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 3102542 · Received May 9, 2013

    Report

    Report Number
    0001831750-2013-04191
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUXILIARY OUTLET ALLEGEDLY MALFUNCTIONED DUE TO A DAMAGED CIRCUIT BREAKER. 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
    203560 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1