BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BEDOBS 01/13

    MDR report key: 3081066 · Received April 26, 2013

    Report

    Report Number
    0001831750-2013-03788
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO CORRECT THE ISSUE FROM POWER CORD TO POWER SUPPLY. THIS CORRECTION WAS DETERMINED DURING THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS A POWER CORD 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 VIA REPAIR WORK ORDER THAT THERE WAS A POWER SUPPLY 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
    182957 SECURE 3 MED/SURG BEDOBS 01/13 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1