BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BEDOBS 01/13

    MDR report key: 3112431 · Received May 14, 2013

    Report

    Report Number
    0001831750-2013-04380
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS INSPECTION WAS ALLEGEDLY PERFORMED BY AN UNKNOWN INDIVIDUAL OF (B)(6). THE ALLEGED INSPECTION IDENTIFIED THAT THE CPU BOARD WAS FAULTY AND A NEW ONE WAS ORDERED. EVAULATION ALLEGEDLY PERFORMED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS NO POWER TO THE CPU BOARD. 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 NO POWER TO THE CPU BOARD. 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
    213589 SECURE 3 MED/SURG BEDOBS 01/13 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1