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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 False Alarm (1013); Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
Explanation: there was no death or device malfunction associated with the inappropriate defibrillation event.There is no indication that the patient sustained a serious injury.Device evaluation summary: monitor sn (b)(4) was returned to the distributor and the evaluation is currently underway.Electrode belt sn(b)(4) has not yet been recovered from the field.Device evaluation included review of downloaded software flag files on the day of 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 inappropriate treatment.Approximately three hours prior to the treatment event, the patient's flags reveal instances of can comm timeout flags which lasted for about three seconds.The few instances of this flag does not indicate a device malfunction that would have contributed to the inappropriate treatment.Device manufacture date: monitor - 05/24/2016; belt - 06/20/2013.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 (response buttons were pressed earlier in the detection sequence but not immediately prior to treatment delivery).The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was motion artifact.The source of the motion artifact could not be positively identified through the cause and effect analysis.The following factors could not be ruled out as contributing causes of the motion artifact: body motion, poor ecg contact with skin.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.(b)(4).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 french patient experienced an inappropriate defibrillation event consisting of one shock.The patient was reportedly driving at the time of the event and reported gel being released.The device was reportedly alarming at the time of the event.The patient called his doctor and went to the hospital.Motion artifact contributed to the false detection.The response buttons were pressed earlier in the detection sequence but not immediately prior to treatment delivery.The response buttons functioned appropriately.The patient remained in the hospital and continued wearing the lifevest.
 
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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
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
Manufacturer Contact
manuela parra
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key8437542
MDR Text Key139364778
Report Number3008642652-2019-01992
Device Sequence Number0
Product Code MVK
Reporter Country CodeUS
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberWCD 4000
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age67 YR
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