BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 3823246 · Received February 27, 2014

    Report

    Report Number
    1824206-2014-00634
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND A LEFT SHEET IN THE WAY OF THE SIDE RAIL LATCHING MECHANISM AND THE BED WAS IN MAX INFLATE TO HELP LIFT THE PT OUT OF THE BED. THIS CAUSED TOO MUCH PRESSURE ON THE SIDE RAIL, PREVENTING IT FROM LATCHING, USER ERROR. AC POWER IS NOT AVAILABLE OR POWER FAILURE HAS OCCURRED. WARNING: A SOUND RISK ASSESSMENT AND PROTOCOL IS NECESSARY TO DETERMINE THE APPROPRIATE SURFACE FOR THE PT'S CONDITION. WARNING: THE OPTIONAL TREATMENT SURFACE IS NOT A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE TREATMENT MODE SHOULD BE USED IN CONJUNCTION WITH GOOD ASSESSMENT AND PROTOCOL. THE TECHNICIAN IN-SERVICED THE ACCOUNT ON HOW TO USE THE LIFT SHEET PROPERLY AND TO TAKE THE MATTRESS OUT OF MAX INFLATE AND THE BED FUNCTIONED AS DESIGNED. NO CORRECTIVE ACTION WAS TAKEN DUE TO THE USER NOT FOLLOWING INSTRUCTIONS AND LABELING. THERE WAS A PT IN THE BED DURING TIME OF FAILURE BUT NO INJURY WAS REPORTED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN THE PT'S HOME. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122771 TOTALCARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1