BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOF WATCH

    MDR report key: 8174231 · Received December 18, 2018

    Report

    Report Number
    3014288445-2018-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Report Date
    January 7, 2019
    Manufacturer
    ORGANON IRELAND LIMITED
    Product Code
    KOI
    PMA / PMN Number
    K925159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD BUM BLISTERS ON THE KNUCKLES OF THE HAND WHICH HAS BEEN PLACED IN THE ARM BOARD DELIVERED BY MSD [BURNS SECOND DEGREE]. PRODUCT QUALITY COMPLAINT WAS REPORTED [DEVICE MALFUNCTION]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM DENMARK WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE AND REFERS TO A PATIENT OF UNKNOWN AGE AND GENDER. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. NO INFORMATION REGARDING THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS WAS PROVIDED. ON (B)(6) 2018, IN RELATION WITH TRAINING TO USE THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) FOR A CLINICAL STUDY, A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT HE PERFORMED A TEST TRACE DURING NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) MONITORING AT A LAPAROSCOPY SURGERY (DURATION 3.5 HOURS). THIS WAS PERFORMED ON A NON-PATIENT (PATIENT NOT RANDOMISED TO A CLINICAL STUDY: (B)(4). AFTER COMPLETION OF THE TEST TRACE IT WAS NOTICED THAT THE PATIENT HAD BURN BLISTERS ON THE KNUCKLES OF THE HAND WHICH HAS BEEN PLACED IN THE ARM BOARD DELIVERED BY MSD (UNSPECIFIED DEVICE MALFUNCTION). THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) WAS NOT AVAILABLE FOR INVESTIGATION. FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH), THE LOT NUMBER AND THE SERIAL NUMBER WERE NOT AVAILABLE. INVESTIGATION REQUESTED, AWAITING RESULTS FROM QUALITY COMPLAINT UNIT (QCU). FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH), QUALITY INVESTIGATION STATUS WAS AS FOLLOWS: THIS CASE MEETS THE INCIDENT CRITERIA DUE TO THE EVENT OF SECOND DEGREE BURNS, AND AS SUCH, AN AE QIR IS REQUIRED AT THIS TIME. COMPLAINT INVESTIGATION REPORT WAS RECEIVED ON 02-JAN-2019. THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM DENMARK WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE REFERS TO A PATIENT OF UNKNOWN AGE AND GENDER, ENROLLED IN AN ANESTHESIA STUDY (B)(4). THE COMPLAINT DESCRIPTION DESCRIBES THAT THE INVOLVED PATIENT HAD BURN BLISTERS ON THE KNUCKLES OF THE HAND WHICH HAS BEEN PLACED IN AN ARM BOARD WHICH SUPPOSEDLY HAVE BEEN PROVIDED BY MSD. UPAN CONSULTATION WITH OUR EXTERNAL SUPPLIER BIOMETER OF THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH), INCLUDING ALL NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) ACCESSORIES, THIS ARM BOARD WAS NOT A STANDARD ACCESSORY. OUR INTERNAL CONTACT, CONTACTED THE INVOLVING INSTITUTE AND REQUESTED FOR MORE INFORMATION REGARDING THIS EVENT. IT WAS STATED THAT THE BLISTERS WERE OBSERVED AT THE PATIENTS HAND/KNUCKLES WHEN THE ARM BOARD WAS REMOVED AFTER DOING THE TEST-TRACE. IT WAS NECESSARY TO REMOVE THE PADDING TO OBTAIN A CALIBRATION WITHIN THE REQUIRED RANGE. THE BLISTERS WERE MOST LIKELY CAUSED BY FRICTION. NO MORE INFORMATION COULD BE RETRIEVED. ONLY A SPECULATIVE ROOT CAUSE FOR THIS COMPLAINT CAN BE FOUND. HOWEVER IT WAS UNLIKELY THE ROOT CAUSE FOR THE COMPLAINT OF THE BURNS ON THE PATIENTS HAND/KNUCKLES IS TO BE FOUND WITHIN MSD OR RELATED TO THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH). THE COMPLAINT WAS REGARDED AS AN INCIDENT AND NO CORRECTIVE ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    THE PATIENT HAD BUM BLISTERS ON THE KNUCKLES OF THE HAND WHICH HAS BEEN PLACED IN THE ARM BOARD DELIVERED BY MSD [BURNS SECOND DEGREE]. PRODUCT QUALITY COMPLAINT WAS REPORTED [DEVICE MALFUNCTION]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM (B)(6) WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE AND REFERS TO A PATIENT OF UNKNOWN AGE AND GENDER. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. NO INFORMATION REGARDING THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS WAS PROVIDED. ON (B)(6) 2018, IN RELATION WITH TRAINING TO USE THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) FOR A CLINICAL STUDY, A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT HE PERFORMED A TEST TRACE DURING NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) MONITORING AT A LAPAROSCOPY SURGERY (DURATION 3.5 HOURS). THIS WAS PERFORMED ON A NON-PATIENT (PATIENT NOT RANDOMISED TO A CLINICAL STUDY: MK-8616-146). AFTER COMPLETION OF THE TEST TRACE IT WAS NOTICED THAT THE PATIENT HAD BURN BLISTERS ON THE KNUCKLES OF THE HAND WHICH HAS BEEN PLACED IN THE ARM BOARD DELIVERED BY MSD (UNSPECIFIED DEVICE MALFUNCTION). THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH) WAS NOT AVAILABLE FOR INVESTIGATION. FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH), THE LOT NUMBER AND THE SERIAL NUMBER WERE NOT AVAILABLE. INVESTIGATION REQUESTED, AWAITING RESULTS FROM QUALITY COMPLAINT UNIT (QCU). FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH), QUALITY INVESTIGATION STATUS WAS AS FOLLOWS: THIS CASE MEETS THE INCIDENT CRITERIA DUE TO THE EVENT OF SECOND DEGREE BURNS, AND AS SUCH, AN AE QIR IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014814 TOF WATCH STIMULATOR, NERVE, PERIPHERAL, ELECTRIC (KOI) KOI ORGANON IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1