BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRX PLUS DETECTOR

    MDR report key: 6555395 · Received May 9, 2017

    Report

    Report Number
    1317307-2017-00009
    Event Type
    Death
    Date Received
    May 9, 2017
    Report Date
    August 21, 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

    THE ROOT CAUSE WAS FOUND TO BE PINCHING OF THE WIRE BETWEEN A METAL POST (BOSS) AND THE REAR COVER OF THE DETECTOR. THE WIRE WAS MOST LIKELY ON TOP OF THE POST SINCE THE UNIT WAS MANUFACTURED AND POSSIBLY SLIPPED ON TOP OF THE POST WHEN THE REAR PORT GASKET WAS BEING INSTALLED. THERE ARE NO IMMEDIATE OR LONG RANGE HEALTH CONSEQUENCES ASSOCIATED WITH THE USE OF THIS DEVICE. IF THE DETECTOR LOSES POWER, AN ALTERNATIVE IMAGING DEVICE OR MODALITY MAY BE NEEDED. THIS FAILURE MODE WAS ADDRESSED IN THE PRODUCT HAZARD RISK ANALYSIS (PHRA) AND RISK MITIGATION (AS DETAILED IN THE PHRA) WAS FOUND TO BE ACCEPTABLE. THIS ISSUE WAS EVALUATED BY CARESTREAM ENVIRONMENTAL HEALTH AND SAFETY AND FOUND NOT TO PRESENT AN ELECTRICAL OR THERMAL HAZARD. AS NOTED IN THE COMPLAINT, THE PATIENT ASSOCIATED WITH THIS INCIDENT EXPIRED. HOWEVER, THE SITE INDICATED THAT THE PATIENT WAS DEAD BEFORE IMAGES WERE ATTEMPTED. THE PATIENT HAD NOT BEEN DECLARED DEAD, SO IT IS HOSPITAL PROTOCOL IN THESE SITUATIONS TO IMAGE THE PATIENT TO DETERMINE PLACEMENT OF A TUBE (IN THE PATIENT). THE FAILURE OF THE DETECTOR DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    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
    336098 DRX PLUS DETECTOR DRX DETECTOR MQB CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death