MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

Patient Problem Death (1802)

Event Date 11/20/2019

Event Type  Death  

Manufacturer Narrative

The electrode belt sn (b)(4) and monitor sn (b)(4) have not been returned.The device flag data from the last download does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.No deficiencies alleged.The patient received two appropriate shocks.Manufacture dates: monitor - 08/20/2015, belt - 01/11/2011.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2019 after receiving two appropriate treatment shocks.Following device startup at 6:42:02 pm on (b)(6)2019, the lifevest detected an arrhythmia at 6:06:22 am of sinus rhythm at 85 bpm degrading to vt at 280 bpm further degrading to vf with motion artifact.At 6:06:47 am, the lifevest declared a non-treatable rhythm.At 6:10:10 am, an arrhythmia of vf with motion artifact was detected.The first treatment pulse was delivered at 6:10:45 am.The patient's rhythm at the time of the treatment delivery was vf and their post-shock rhythm was vf at 280 bpm with motion artifact.The energy delivered in this treatment pulse was 112 joules.The second treatment pulse was delivered at 6:11:45 am.The patient's rhythm at the time of the treatment delivery was vt/vf at 280 bpm with motion artifact and their post-shock rhythm was vf with motion artifact.The energy delivered in this treatment pulse was 136 joules.The low energy pulses were caused by high impedance.The cause of the high impedance is unknown.The device properly delivered conductive gel during the event.There is no indication that the high impedance was caused by a device malfunction.Following the treatment pulses, the device declared a non-treatable rhythm at 6:11:40 am.Then, from 6:13:46 to 6:17:42 am, the device detected an arrhythmia three times.The patient's rhythm was vt at 270 bpm slowing to vt at 200 bpm with motion artifact.The device then declared a non-treatable rhythm at 6:18:10 am.The device properly detected vt.However, motion artifact and tactile artifact obscured the rhythm therefore the patient was not treated by the lifevest.It was reported that the patient was transported to the hospital via emergency medical services where resuscitation attempts were unsuccessful.

Manufacturer Narrative

The electrode belt sn (b)(6) and monitor sn (b)(6) have not been returned.The device flag data from the last download does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.No deficiencies alleged.The patient received two appropriate shocks.Manufacture dates: monitor - 08/20/2015.Belt - 01/11/2011.Device evaluation of electrode belt sn (b)(6) has been completed.Upon investigation the electrode belt failed an ecg fall-off test.The cable connecting ecg "a" and ecg "b" was pulled from the strain relief, damaging the j703 connector on the distribution node pca.It was reported that resuscitation was attempted on this patient.The damage to the electrode belt may have resulted from the resuscitation attempts.The root cause for the strained cable was excessive force.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2019 after receiving two appropriate treatment shocks.Following device startup at 6:42:02 pm on (b)(6) 2019, the lifevest detected an arrhythmia at 6:06:22 am of sinus rhythm at 85 bpm degrading to vt at 280 bpm further degrading to vf with motion artifact.At 6:06:47 am, the lifevest declared a non-treatable rhythm.At 6:10:10 am, an arrhythmia of vf with motion artifact was detected.The first treatment pulse was delivered at 6:10:45 am.The patient's rhythm at the time of the treatment delivery was vf and their post-shock rhythm was vf at 280 bpm with motion artifact.The energy delivered in this treatment pulse was 112 joules.The second treatment pulse was delivered at 6:11:45 am.The patient's rhythm at the time of the treatment delivery was vt/vf at 280 bpm with motion artifact and their post-shock rhythm was vf with motion artifact.The energy delivered in this treatment pulse was 136 joules.The low energy pulses were caused by high impedance.The cause of the high impedance is unknown.The device properly delivered conductive gel during the event.There is no indication that the high impedance was caused by a device malfunction.Following the treatment pulses, the device declared a non-treatable rhythm at 6:11:40 am.Then, from 6:13:46 to 6:17:42 am, the device detected an arrhythmia three times.The patient's rhythm was vt at 270 bpm slowing to vt at 200 bpm with motion artifact.The device then declared a non-treatable rhythm at 6:18:10 am.The device properly detected vt.However, motion artifact and tactile artifact obscured the rhythm therefore the patient was not treated by the lifevest.It was reported that the patient was transported to the hospital via emergency medical services where resuscitation attempts were unsuccessful.During the investigation of an electrode belt following a patient death, a reportable malfunction was found.

• 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 Key: 9505534
• MDR Text Key: 172285838
• Report Number: 3008642652-2019-10304
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 55 YR