BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDET TAXABLE

    MDR report key: 5141335 · Received October 9, 2015

    Report

    Report Number
    3006433555-2015-00402
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    March 17, 2015
    Report Date
    September 14, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY CUSTOMER WHICH DETERMINED THERE WAS NO BED MALFUNCTION. NO FURTHER INFORMATION OR CONFIRMATION WAS AVAILABLE REGARDING WHETHER THE ALARM WAS SET PRIOR TO THE ALLEGED EVENT. IT WAS REPORTED THAT THE PATIENT SUSTAINED A MINOR BRUISE TO THE KNEE AND THIGH; HOWEVER, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED EXIT ALLEDGEDLY DID NOT ALARM AND A PATIENT FELL FROM THE BED, HOWEVER, IT WAS ALSO REPORTED THAT THE ALARM DID GO OFF WHEN THE BED WAS TESTED. THE PATIENT ALLEDGEDLY SUSTAINED MINOR KNEE AND THIGH WOUNDS THAT DID NOT REQUIRE URGENT CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED EXIT ALLEGEDLY DID NOT ALARM AND A PATIENT FELL FROM THE BED, HOWEVER, IT WAS ALSO REPORTED THAT THE ALARM DID GO OFF WHEN THE BED WAS TESTED. THE PATIENT ALLEGEDLY SUSTAINED MINOR KNEE AND THIGH WOUNDS THAT DID NOT REQUIRE URGENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672507 MDET TAXABLE BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1