BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRO-2000 BLOWER

    MDR report key: 275434 · Received April 17, 2000

    Report

    Report Number
    275434
    Event Type
    Other
    Date Received
    April 17, 2000
    Date of Event
    April 5, 2000
    Report Date
    April 15, 2000
    Manufacturer
    CARDIOSYSTEMS OWNED BY MEDIQ PRN
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS A RESIDENT OF LONG TERM CARE NURSING FACILITY. THE PT WAS PLACED ON A SPECIALIZED BED ON 03/17/2000 TO PROMOTE HEALING AND PREVENT PRESSURE ULCERS. ON 04/05/2000, THE RESIDENT WAS FOUND WITH A 2 & 3RD DEGREE BURNS ON THE LEFT FOOT. THE MOTOR OF THE SPECIALIZED BED (PRO-2000) WAS MOUNTED TO THE FOOT BOARD. THE RESIDENT WAS FOUND WITH FOOT AGAINST MOTOR. THE REP WAS CONTACTED. THE BED WAS RETURNED TO THE CO ON 04/05/2000 FOR TESTING. ALL OTHER PRO-2000 BEDS IN USE HAD BRACKETS ATTACHED TO HAVE MOTOR LOWERED AWAY FROM PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-2000 BLOWER SPECIALTY BED INX CARDIOSYSTEMS OWNED BY MEDIQ PRN PRO-2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other