BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLCAM RECORDER DR3

    MDR report key: 9671047 · Received February 5, 2020

    Report

    Report Number
    9671047
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 9, 2020
    Manufacturer
    GIVEN IMAGING, INC.
    Product Code
    NEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    INPATIENT IN TICU WAS SCHEDULED FOR CAPSULE ENDOSCOPY. PROTOCOL FOLLOWED TO PREPARE AND PAIR CAPSULE AND RECORDER WITHOUT ANY DIFFICULTIES. NURSE HAD PATIENT SWALLOW CAPSULE. WITHIN 10 MINUTES, RECORDER FLASHING YELLOW LIGHT EVERY 5 SECONDS INDICATING THAT THE RECORDER WAS NOT RECEIVING SIGNALS FROM THE CAPSULE. NURSE CALLED MEDTRONIC TECH SUPPORT TO TROUBLESHOOT PROBLEM. AFTER ATTEMPTS TO CORRECT ISSUE, THE RECORDER DID CONTINUE WITH THE FLASHING YELLOW LIGHT EVERY 5 SECONDS. WHEN THE RECORDER WAS DOWNLOADED, THE STUDY SHOWED THE CAPSULE SIGNALS WERE NOT DETECTED BY THE RECORDER. THE STUDY WAS INCOMPLETE. THE CONCLUSION WAS THAT THE PATIENT WAS ON TELEMETRY WHICH CAN CAUSE INTERFERENCE WITH THE CAPSULE STUDY. USING DIFFERENT EQUIPMENT, THE CAPSULE STUDY WAS REPEATED WITH THE PATIENT OFF TELEMETRY (PATIENT REMAINED IN TICU). THERE WERE EPISODES WHERE THE YELLOW LIGHT WOULD FLASH EVERY 5 SECONDS. THE STUDY DID SHOW THAT THERE WAS INTERFERENCE AND THAT THE CAPSULE SIGNAL WAS NOT RECEIVED BY THE RECORDER. THIS STUDY WAS ALSO INCOMPLETE. PILLCAM RECORDER REF: FGS-0347 AND CAPSULE: CAPSULE IDS: VVS-3TA-V AND MHX-6CC-M.

    Description of Event or Problem · 1

    INPATIENT IN TICU WAS SCHEDULED FOR CAPSULE ENDOSCOPY. PROTOCOL FOLLOWED TO PREPARE AND PAIR CAPSULE AND RECORDER WITHOUT ANY DIFFICULTIES. NURSE HAD PATIENT SWALLOW CAPSULE. WITHIN 10 MINUTES, RECORDER FLASHING YELLOW LIGHT EVERY 5 SECONDS INDICATING THAT THE RECORDER WAS NOT RECEIVING SIGNALS FROM THE CAPSULE. NURSE CALLED MEDTRONIC TECH SUPPORT TO TROUBLESHOOT PROBLEM. AFTER ATTEMPTS TO CORRECT ISSUE, THE RECORDER DID CONTINUE WITH THE FLASHING YELLOW LIGHT EVERY 5 SECONDS. WHEN THE RECORDER WAS DOWNLOADED, THE STUDY SHOWED THE CAPSULE SIGNALS WERE NOT DETECTED BY THE RECORDER. THE STUDY WAS INCOMPLETE. THE CONCLUSION WAS THAT THE PATIENT WAS ON TELEMETRY WHICH CAN CAUSE INTERFERENCE WITH THE CAPSULE STUDY. USING DIFFERENT EQUIPMENT, THE CAPSULE STUDY WAS REPEATED WITH THE PATIENT OFF TELEMETRY (PATIENT REMAINED IN TICU). THERE WERE EPISODES WHERE THE YELLOW LIGHT WOULD FLASH EVERY 5 SECONDS. THE STUDY DID SHOW THAT THERE WAS INTERFERENCE AND THAT THE CAPSULE SIGNAL WAS NOT RECEIVED BY THE RECORDER. THIS STUDY WAS ALSO INCOMPLETE. PILLCAM RECORDER REF: FGS-0347 AND CAPSULE. CAPSULE IDS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135521 PILLCAM RECORDER DR3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN IMAGING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8395 DA