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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR
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ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Dizziness (2194); Shock from Patient Lead(s) (3162)
Event Date 08/22/2020
Event Type  Injury  
Manufacturer Narrative
There was no death or device malfunction associated with the inappropriate defibrillation event.Device evaluation summary: device evaluation of monitor sn (b)(4) has been completed at the distributor.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.Electrode belt sn (b)(4) has been returned to the distributor but has not been evaluated yet.Device evaluation includes review of downloaded software flag files on the days surrounding the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the patient treatment.Manufacture dates monitor - 07152296 - 04/22/2016 electrode belt - (b)(4) - 06/15/2012 additional inappropriate defibrillation narrative the investigation into the event concludes that there was no device malfunction.A cause and effect analysis was conducted using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips.The primary cause of the inappropriate shock was improper response button use by the patient during the false detection.The response buttons were pressed after the treatment event.The response buttons functioned appropriately.The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was oversensing of low-amplitude cardiac signal and multiple counting.The multiple counting satisfied the rate detector of the detection algorithm.Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69% per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The lifevest detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.
 
Event Description
A us distributor contacted zoll to report that a german experienced an inappropriate defibrillation event consisting of one shock.It was reported that the patient had felt dizzy before experiencing the treatment.The response buttons were pressed after the treatment event.The response buttons functioned appropriately.Oversensing of low-amplitude cardiac signal and multiple counting contributed to the false detection.The multiple counting satisfied the rate detector of the detection algorithm.The patient received medical attention at a hospital and received an icd.There was no death or device malfunction associated with the inappropriate defibrillation event.
 
Manufacturer Narrative
Explanation of h.1: there was no death or device malfunction associated with the inappropriate defibrillation event.H.3 device evaluation summary: device evaluation of monitor sn (b)(6) has been completed at the distributor.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.Electrode belt sn (b)(6) has been returned to the distributor but has not been evaluated yet.Device evaluation includes review of downloaded software flag files on the days surrounding the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the patient treatment.H.4 manufacture dates: monitor - 07152296 - 04/22/2016.Electrode belt - 59036793 - 06/15/2012.H.10 additional inappropriate defibrillation narrative the investigation into the event concludes that there w:as no device malfunction.A cause and effect analysis was conducted (attached) using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips (attached).The primary cause of the inappropriate shock was improper response button use by the patient during the false detection.The response buttons were pressed after the treatment event.The response buttons functioned appropriately.The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was oversensing of low-amplitude cardiac signal and multiple counting.The multiple counting satisfied the rate detector of the detection algorithm.Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69% per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The lifevest detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.Correction: h1 was errantly marked as 'death' when it should have been marked as 'serious injury'.
 
Event Description
A us distributor contacted zoll to report that a german experienced an inappropriate defibrillation event consisting of one shock.It was reported that the patient had felt dizzy before experiencing the treatment.The response buttons were pressed after the treatment event.The response buttons functioned appropriately.Oversensing of low-amplitude cardiac signal and multiple counting contributed to the false detection.The multiple counting satisfied the rate detector of the detection algorithm.The patient received medical attention at a hospital and received an icd.There was no death or device malfunction associated with the inappropriate defibrillation event.A correction to the initial report is being submitted.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
MDR Report Key10589619
MDR Text Key208976939
Report Number3008642652-2020-08379
Device Sequence Number1
Product Code MVK
UDI-Device Identifier00855778005005
UDI-Public00855778005005
Combination Product (y/n)Y
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberWCD 4000
Device Catalogue Number10A0988
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age55 YR
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