BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST GENERIC

    MDR report key: 5020753 · Received August 21, 2015

    Report

    Report Number
    9615739-2015-00251
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    HILL-ROM FRANCE
    Product Code
    FNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT HAS PAGED A FIELD TECHNICIAN TO REPAIR THE BED. PER THE HILL-ROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. HEAD SECTION MOTOR: INSPECT THE ACTUATOR ASSEMBLY. MAKE SURE THE PINS AND RETAINING CLIPS ARE INTACT AND NOT MISSING. FULLY RAISE AND LOWER THE HEAD SECTION. MAKE SURE THERE IS NO FRICTION OR ABNORMAL NOISES AND THAT NO AUDIBLE OVERLOAD INDICATION CAN BE HEARD DURING THE MOVEMENT. REPAIR AS NECESSARY. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE HEAD SECTION WOULD SELF-RUN WHEN THE BED IS PLUGGED IN. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555935 CARE ASSIST GENERIC A/C POWERED ADJUSTABLE HOSPITAL BED FNK HILL-ROM FRANCE P1170B

    Patients

    Seq Age Sex Outcome Treatment
    1