BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 2950972 · Received February 8, 2013

    Report

    Report Number
    0001831750-2013-00906
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THAT THE FOWLER WOULD NOT LOWER ELECTRONICALLY AND THERE WAS NOT AN ISSUE WITH THE SCALE. THIS WILL RESULT IN CAREGIVER ANNOYANCE; HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS THE MANUAL CPR RELEASE WAS ABLE TO LOWER THE FOWLER TO THE LOWEST POSITION WHICH IS DESIRED FOR CPR ADMINISTRATION, IF REQUIRED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE WAS NOT WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOWLER WAS UNABLE TO LOWER ELECTRONICALLY. HOWEVER, THE MANUAL CPR RELEASE WAS ABLE TO LOWER THE FOWLER. 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
    54541 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1