BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRX PLUS DETECTOR

    MDR report key: 6575643 · Received May 18, 2017

    Report

    Report Number
    1317307-2017-00012
    Event Type
    Death
    Date Received
    May 18, 2017
    Report Date
    May 30, 2017
    Manufacturer
    CARESTREAM HEALTH INC
    Product Code
    MQB
    PMA / PMN Number
    150766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED IN ERROR AND THE EVENT IS DOCUMENTED IN REPORT 1317303 -2017 -00009.

    Additional Manufacturer Narrative · 1

    ON MAY 18 2017 - REPORT FAILED TO UPLOAD TO CDHR DUE TO DUPLICATE REPORT NUMBER, THIS ERROR HAS BEEN CORRECTED AND THEREFORE REPORT RESUBMITTED. THE CURRENT FACTS AVAILABLE INDICATE THAT THIS INCIDENT WAS NOT THE RESULT OF A MALFUNCTION OF THE CARESTREAM DRX PLUS DETECTOR. PER THE HOSPITAL, THEIR TECHNOLOGIST INCORRECTLY POSITIONED THE DETECTOR IN RELATION TO THE THUMPER WHICH INTERFERED WITH BATTERY FUNCTION AND CAUSED THE LOSS OF POWER TO THE DETECTOR. CARESTREAM HEALTH (CSH) HAS INITIATED A FORMAL INVESTIGATION INTO THIS INCIDENT THAT WILL BE MANAGED THROUGH THE CSH CAPA SYSTEM. A FOLLOW UP REPORT WILL BE SUBMITTED TO THE FDA AS SOON AS ADDITIONAL FACTS ARE AVAILABLE. CARESTREAM HEALTH (CSH) MDR 1317307 2017 00009 WAS ERRONEOUSLY SUBMITTED ON 09-MAY-2017 AS A 5 DAY REPORT. THIS REPORT SHOULD HAVE BEEN SUBMITTED AS A 30 DAY AS CSH WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE FOLLOWING: A PATIENT WAS ON THE TABLE WITH THE DRX PLUS DETECTOR BETWEEN A THUMPER (MECHANICAL HEART COMPRESSION DEVICE; NOT MANUFACTURED OR SUPPLIED BY CARESTREAM HEALTH AND THE PATIENT. THE PATIENT DIED ON THE TABLE WITH THE DETECTOR UNDER THE PATIENT WHILE THE TECHNOLOGIST WAS IN THE PROCESS OF TRYING TO TAKE AN EXPOSURE. THE EXPOSURE WAS NOT ABLE TO BE TAKEN DUE TO LOSS OF POWER TO THE DETECTOR.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE FOLLOWING: A PATIENT WAS ON THE TABLE WITH THE DRX PLUS DETECTOR BETWEEN A THUMPER (MECHANICAL HEART COMPRESSION DEVICE; NOT MANUFACTURED OR SUPPLIED BY CARESTREAM HEALTH AND THE PATIENT. THE PATIENT DIED ON THE TABLE WITH THE DETECTOR UNDER THE PATIENT WHILE THE TECHNOLOGIST WAS IN THE PROCESS OF TRYING TO TAKE AN EXPOSURE. THE EXPOSURE WAS NOT ABLE TO BE TAKEN DUE TO LOSS OF POWER TO THE DETECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357792 DRX PLUS DETECTOR DRX DETECTOR MQB CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death