BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIADYNE II THERAPY SYSTEM

    MDR report key: 1242931 · Received November 21, 2008

    Report

    Report Number
    1625774-2008-00059
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    IKZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DIRECTOR OF NURSING (DON), THE PATIENT HAD BEEN ON THE BED 22 DAYS PRIOR TO THE REPORTED EVENT. THE DON STATED THAT THE BED PLAYED NO ROLE IN THE ADVERSE EVENT AND ALSO STATED THAT THE NURSES BELIEVE THE CPR WAS INADVERTENTLY ENGAGED CAUSING THE DEFLATION OF THE BED. THIS EVENT IS BEING REPORTED DUE TO MEDICAL INTERVENTION REQUIRED TO RESOLVE PATIENT'S CONDITION. DEVICE EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRIADYNE II BED DEFLATED WHILE PATIENT WAS BEING BATHED. THE PATIENT WAS IN A FLAT, SUPINE POSITION. IT WAS ALSO REPORTED THAT SHORTLY AFTER DEFLATION, THE PATIENT CODED AND REQUIRED RESUSCITATION. ACCORDING TO THE NURSE, THE PATIENT RECOVERED FROM THE REPORTED EVENT AND THE PATIENT'S CONDITION AS REPORTED IN 2008, WAS THE SAME AS UPON ADMISSION TO THE HOSPITAL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIADYNE II THERAPY SYSTEM BED, ROTATION THERAPY, POWERED IKZ KCI USA, INC. TRIADYNE II

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R PRIMAXIN 250 MG IV QD| NORVASC 10 MG QD| AMIKACIN 600 MG Q 48 HRS| PROPOFOL INFUSION CONTINUOUSLY| MORPHINE 1-2 MG PRN| LANTUS 35 UNITS QD| REGULAR INSULIN ON SLIDING SCALE| 5000 U HEPARIN Q 8 HRS SUB Q| LOPRESSOR 200 MG Q 12 HRS| CLONIDINE PATCH 3 MG Q 24 HRS| ALBUTEROL TX Q 4 HOURS| CHLORHEXIDINE BID| PREVICID 30 MG QD| APRESSOLINE 50 MG Q 8 HRS