BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX SELECT MULTIFUNCTION DEFIB PADS - NISSHA VERMED

    MDR report key: 15520417 · Received September 30, 2022

    Report

    Report Number
    1317188-2022-00011
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 30, 2022
    Manufacturer
    GRAPHIC CONTROLS DBA 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 RGA 183621-QC. 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 RGA 183621-QC 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 THE EVENT IS BEING REPORTED.

    Description of Event or Problem · 0

    ON THE (B)(6) 2022 CALL, THE CREW APPLIED PADS THE PADS IN AN ATTEMPT TO CARDIOVERT THE PATIENT BUT THEY FAILED. END USER UNABLE TO PROVIDE DETAIL ABOUT THE FAILURE OTHER THAN NOT BEING ABLE TO PROVIDE TREATMENT. NO SIGNAL FROM THE DEVICE. FORTUNATELY THEY WERE ABLE TO TREAT THE PATIENT MEDICALLY AND TRANSPORTED THEM WITHOUT FURTHER INCIDENT. PHYSIO-CONTROL LP15 2021 MODEL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647270 CURAPLEX SELECT MULTIFUNCTION DEFIB PADS - NISSHA VERMED DEFIBRILLATOR PAD MKJ GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES 16384 Y121721-06, Y012522-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other