BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT

    MDR report key: 5057093 · Received September 4, 2015

    Report

    Report Number
    3006433555-2015-00368
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 11, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY CUSTOMER WHICH DETERMINED THE FOOTBOARD LOOSING CONNECTIVITY WAS LIKELY DUE TO A DAMAGED BLIND MATE ASSEMBLY. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED EXIT ALLEGEDLY DID NOT ALARM DUE TO THE FOOTBOARD NOT HAVING POWER. THE PATIENT ALLEGEDLY EXITED THE BED AND SUBSEQUENTLY FELL IN THE RESTROOM. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED EXIT ALLEGEDLY DID NOT ALARM DUE TO THE FOOTBOARD NOT HAVING POWER. THE PATIENT ALLEGEDLY EXITED THE BED AND SUBSEQUENTLY FELL IN THE RESTROOM. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589622 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1