BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILLIPS HEARTSTART MRX 3536A

    MDR report key: 1649759 · Received April 2, 2010

    Report

    Report Number
    MW5015368
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    April 28, 2009
    Report Date
    April 2, 2010
    Manufacturer
    PHILLIPS HEALTHCARE INC. (PHILMEDISYSTB)
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF CHEST PAIN, EMT'S DISPATCHED TO HOME. PT WAS GIVEN MORPHINE FOR ANXIETY. PT DID NOT WANT TO LAY FLAT, DUE TO HISTORY OF CHF. MORPHINE CAUSED RESPIRATORY DISTRESS AND THEN CARDIOPULMONARY ARREST. PHILLIPS MONITOR WAS READING ZERO HEART RATE AND MULTIPLE ERROR MESSAGES. WIFE STATES THAT EMT'S LIED AND STATED THAT PT WAS PULLING LEADS OFF. WIFE WAS TRANSPORTED WITH PT TO HOSPITAL. PT DIED. WIFE OBTAINED EVENT SUMMARY AND SAW THAT THE MONITOR NEVER PACED THE PT. MONITOR SHOULD HAVE BEEN PULLED OUT OF SERVICE. PHILIPS DIDN'T CONTACT COUNTY UNTIL (B) (6) 2009 FOR REPAIRS. (B) (6) IS STILL USING 4 OF THESE DEVICES AFTER THE RECALL. ANOTHER RECALL TOOK PLACE IN 7/09, AFTER THE REPAIRS. (B) (4). (B) (6) WAS NOTIFIED OF THE PROBLEM IN 7/08, 1 YEAR BEFORE THE U.S. PHILIPS HAS MADE THE USER AWARE OF 6 ITEMS, AND THAT IF ANY ARE NOTICED, DEVICE IS TO BE TAKEN OUT OF SERVICE-(B) (6). IS NON COMPLIANT WITH RECALL. (B) (4). CAUSE OF DEATH - OPIATE INTOXICATION. AGGRAVATING ATHEROSCLEROTIC ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS HEARTSTART MRX 3536A MONITOR/DEFIBRILLATOR (MKJ) MKJ PHILLIPS HEALTHCARE INC. (PHILMEDISYSTB)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| O