BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BEDOBS 01/13

    MDR report key: 3241038 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06542
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PERFORMED AN EVALUATION AND DETERMINED THE FOWLER WAS DRIFTING; HOWEVER, THE BED COULD NOT BE LOCATED TO PERFORM BY A STRYKER TECH TO PERFORM AN EVALUATION CUSTOMER TO CONTACT STRYKER IF THEY LOCATE THE BED AND WISH TO REPAIR IT IN THE FUTURE. CUSTOMER PERFORMED EVALUATION.

    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 BY REPAIR WORK ORDER THAT THE FOWLER WAS DRIFTING DOWN. 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 BY REPAIR WORK ORDER THAT THE FOWLER WAS DRIFTING DOWN. 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
    340084 SECURE 3 MED/SURG BEDOBS 01/13 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1