BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURAPLEX SELECT MULTIFUNCTION DEFIB PADS

    MDR report key: 15520426 · Received September 30, 2022

    Report

    Report Number
    1317188-2022-00010
    Event Type
    Death
    Date Received
    September 30, 2022
    Date of Event
    August 12, 2022
    Report Date
    September 14, 2022
    Manufacturer
    NISSHA MEDICAL TECHNOLOGIES
    Product Code
    MKJ
    PMA / PMN Number
    K080421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT #Y121721-06 - DHR REVIEW DID NOT REVEAL ANY NON-CONFORMANCES OR ANOMALIES. THE SINGLE LOT REPRESENTATIVE SAMPLE PASSED ALL ELECTRICAL FOR PRE-AND POST-PACE TESTING VIA USE A PHYSIO CONTROL MATING CONNECTOR SO THAT THE COMPLETE PAD ASSEMBLY IS TESTED, I.E., THROUGH THE CONNECTOR AND PAD ASSEMBLY. A REVIEW OF THE COMPLAINT LOG DID NOT REVEAL ANY OTHER COMPLAINTS WITH THIS LOT NUMBER FOR THIS ISSUE: NO TRENDING OBSERVED. TESTING OF 2 SEALED/UNOPENED PACKAGES RETURNED BY THE CUSTOMER VIA (B)(6). TESTING AND VISUAL INSPECTION OF THE TWO RETURNED, UNOPENED/UNUSED PADS DID NOT REVEAL ANY ANOMALIES. BOTH PAD SETS WERE IMMEDIATELY RECOGNIZED BY A PHYSIO CONTROL LIFEPAK 12 AND LIFEPAK 20E IN "ANALYZE OR AED MODE". THE SIMULATED VFIB1 WAVEFORM, GENERATED VIA A FLUKE 4000 DEFIBRILLATOR ANALYZER, WAS DISPLAYED ON BOTH DEFIBRILLATOR MONITORS AS SOON AS THE PADS SET WERE CONNECTED TO THE TESTING CIRCUIT. USING THE "ANALYZE" MODE ON THE LIFEPAK 12, THREE DEFIBRILLATION SHOCKS WERE MANUALLY DELIVERED AT 200J, 300J AND 360J, AFTER "SHOCK ADVISED" NOTIFICATION WAS DISPLAYED ON THE MONITOR ON BOTH PADS. THE VFIB WAVEFORM WAS CONTINUALLY DISPLAYED ON THE DEFIBRILLATOR MONITOR. NO ALARMS, OR LOSS OF EKG SIGNAL, OR DELAY IN THERAPEUTIC SHOCK OCCURRED DURING THE TESTING. UPON COMPLETION OF TESTING USING THE LIFEPAK12, THE PADS WERE CONNECTED TO THE PHYSIO CONTROL LIFEPAK20E IN AED MODE. THE VFIB WAVEFORM WAS ONCE AGAIN IMMEDIATELY DISPLAYED ONTO THE DEFIBRILLATOR MONITOR. THE "ANALYZE" BUTTON WAS PRESSED. THE DEFIBRILLATOR INDICATED "SHOCK ADVISED" AND CHARGED TO 360J. A SINGLE 360J DISCHARGE WAS MANUALLY DELIVERED WITHOUT ISSUE. THE VFIB WAVEFORM IMMEDIATELY DISPLAYED ON THE MONITOR FOLLOWING THE DISCHARGE. NO ALARMS, OR LOSS OF EKG SIGNAL, OR DELAY IN THERAPEUTIC SHOCK OCCURRED DURING THE TESTING. LOT #Y012522-08 - DHR REVIEW DID NOT REVEAL ANY NON-CONFORMANCES OR ANOMALIES. THE SINGLE LOT REPRESENTATIVE SAMPLE PASSED ALL ELECTRICAL FOR PRE-AND POST-PACE TESTING VIA USE A PHYSIO CONTROL MATING CONNECTOR SO THAT THE COMPLETE PAD ASSEMBLY IS TESTED, I.E., THROUGH THE CONNECTOR AND PAD ASSEMBLY. ALL VALUES WERE WELL WITHIN UPPER LIMIT SPECIFICATIONS. A REVIEW OF THE COMPLAINT LOG DID NOT REVEAL ANY OTHER COMPLAINTS WITH THIS LOT NUMBER FOR THIS ISSUE: NO TRENDING OBSERVED. TESTING OF 3 SEALED/UNOPENED PACKAGES RETURNED BY THE CUSTOMER VIA (B)(6). TESTING AND VISUAL INSPECTION OF THE THREE OF THE 14 RETURNED, UNOPENED/UNUSED PADS DID NOT REVEAL ANY ANOMALIES. ALL THREE PAD SETS WERE IMMEDIATELY RECOGNIZED BY A PHYSIO CONTROL LIFEPAK 12 AND LIFEPAK 20E IN "ANALYZE OR AED MODE". THE SIMULATED VFIB1 WAVEFORM, GENERATED VIA A FLUKE 4000 DEFIBRILLATOR ANALYZER, WAS DISPLAYED ON BOTH DEFIBRILLATOR MONITORS AS SOON AS THE PADS SET WERE CONNECTED TO THE TESTING CIRCUIT. USING THE "ANALYZE" MODE ON THE LIFEPAK 12, THREE DEFIBRILLATION SHOCKS WERE MANUALLY DELIVERED AT 200J, 300J AND 360J, AFTER "SHOCK ADVISED" NOTIFICATION WAS DISPLAYED ON THE MONITOR ON ALL THREE PADS. THE VFIB WAVEFORM WAS CONTINUALLY DISPLAYED ON THE DEFIBRILLATOR MONITOR. NO ALARMS, OR LOSS OF EKG SIGNAL, OR DELAY IN THERAPEUTIC SHOCK OCCURRED DURING THE TESTING. UPON COMPLETION OF TESTING USING THE LIFEPAK12, THE THREE PAD SETS WERE CONNECTED TO THE PHYSIO CONTROL LIFEPAK20E IN AED MODE. THE VFIB WAVEFORM WAS ONCE AGAIN IMMEDIATELY DISPLAYED ONTO THE DEFIBRILLATOR MONITOR. THE "ANALYZE" BUTTON WAS PRESSED. THE DEFIBRILLATOR INDICATED "SHOCK ADVISED" AND CHARGED TO 360J. A SINGLE 360J DISCHARGE WAS MANUALLY DELIVERED WITHOUT ISSUE. THE VFIB WAVEFORM IMMEDIATELY DISPLAYED ON THE MONITOR FOLLOWING THE DISCHARGE. NO ALARMS, OR LOSS OF EKG SIGNAL, OR DELAY IN THERAPEUTIC SHOCK OCCURRED DURING THE TESTING. PER TESTING OF THE SAMPLES SENT BACK FROM THE CUSTOMER, THE MALFUNCTION CANNOT BE REPLICATED. HOWEVER, SINCE THE INVESTIGATION CANNOT PROVE THAT A MALFUNCTION DID NOT OCCUR WITH THE SPECIFIC SET OF PADS, THE EVENT IS BEING REPORTED.

    Description of Event or Problem · 0

    ON THE CARDIAC ARREST, (B)(6) 2022, THE CREW INITIATED TREATMENT AND THE PATIENT WAS IN VENTRICULAR FIBRILLATION AND THE PADS WOULD NOT WORK. THEY SWAPPED THEM OUT WITH A SPARE SET, WOULD NOT WORK, UNPLUGGED THE CABLE FROM THE MONITOR ITSELF, PLUGGED IT BACK IN AND THEN THEY WERE ABLE TO CONTINUE THE CALL WITHOUT FURTHER INCIDENT DUE TO THE 2ND SET WORKING. TREATMENT WAS ABLE TO BE PROVIDED HOWEVER, THE PATIENT DID EXPIRE. THE SECOND SET OF PADS WORKED AFTER UNPLUGGING AND PLUGGING BACK IN AND THEN THEY PERFORMED PROPERLY. PHYSIO-CONTROL LP15 2021 MODEL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647878 CURAPLEX SELECT MULTIFUNCTION DEFIB PADS RADIOTRANSLUCENT DEFIBRILLATION ELECTRODE MKJ NISSHA MEDICAL TECHNOLOGIES 16384 Y121721-06, Y012522-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Death