BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 2897420 · Received December 7, 2012

    Report

    Report Number
    1824206-2012-07908
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    June 18, 2012
    Report Date
    November 6, 2012
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INVESTIGATED BY HILL-ROM. THE ACCOUNT WAS UNABLE TO PROVIDE INFORMATION AS TO WHICH BED WAS INVOLVED WITH THIS EVENT AND COULD NOT PROVIDE A SERIAL NUMBER. THE CUSTOMER STATED "THE MATTRESS LOOKED FULLY INFLATED FROM THE SIDE". THIS IS VERY SUBJECTIVE, THE ONLY WAY TO DETERMINE THE MATTRESS WAS NOT FULLY INFLATED WOULD BE TO TAKE A PRESSURE MEASUREMENT. AN ALARM WOULD ONLY OPERATE INTERMITTENTLY IF THERE WAS A COMPONENT OR SYSTEM MALFUNCTION; TYPICALLY THEY ARE SET AND REQUIRE A MANUAL RESETTING TO REMOVE THEM. HILL-ROM HAS RECEIVED FIVE ALLEGED COMPLAINTS WITHIN THE LAS THREE YEARS FOR SKIN BREAKDOWN RELATED TO MATTRESS INFLATE/DEFLATE ISSUES, WITH AN INSTALL BASE OF 1,000,000 UNITS. ISSUES: ELECTRICAL CONNECTION ISSUE, HOME ACCOUNT - WAS UNABLE TO FOLLOW UP AS CUSTOMER WOULD NOT ANSWER THE PHONE OR ALLOW THE TECH IN THE HOUSE, ACCOUNT DID NOT KNOW WHICH BED MALFUNCTIONED - NO ROOT CAUSE PERFORMED, ISSUES WERE THERE WAS NO PROBLEM FOUND. THIS PRODUCT FALLS WITHIN THE FNL (BED, AC-POWERED ADJUSTABLE HOSPITAL) AND IOQ (BED, FLOTATION THERAPY, POWERED) FAMILY.

    Description of Event or Problem · 1

    THIS REPORT IS IN RESPONSE TO FDA REQUEST LETTER (REPORT NUMBER(B)(4)). RECEIVED BY HILL-ROM NOVEMBER 05, 2012. CUSTOMER EVENT DESCRIPTION: "PATIENT ON A ROTATING MATTRESS. THE THORACIC PORTION OF THE PATIENT'S MATTRESS DID NOT FULLY RE-INFLATE. THERE WAS NO AIR LEAK ALARM THROUGHOUT THE DAY AND THE MATTRESS LOOKED FULLY INFLATED FROM THE SIDE. AIR LEAK ALARM SOUNDED LATER IN THE DAY AND BED WAS IMMEDIATELY REPLACED. TWO SMALL AREAS OF STAGE II SKIN BREAKDOWN NOTED ON PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other