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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Disconnection (1171); Over-Sensing (1438); Device Stops Intermittently (1599)

Patient Problem Death (1802)

Event Date 03/02/2016

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was confirmed.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 monitor malfunction.Device evaluation of electrode belt sn (b)(4) has been completed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was pulled from the strain relief, damaging wires in the cable.The root cause for the strained cable was excessive force.As the electrode belt was able to detect an ecg signal and deliver treatments during the event, it is likely that the damage to the cable occurred during device removal.There is no indication that the damaged cable caused or contributed to the patient's death.

Event Description

A us distributor contacted zoll to report that the patient passed away on (b)(6) 2016 while wearing the lifevest.The patient was in a rehabilitation facility at the time of the event.The patient was walking to the restroom and was reportedly feeling unwell.Facility staff returned the patient to his bed and began performing cpr.The patient was transported to the hospital where he was pronounced dead.Download data revealed that the lifevest treated the patient fourteen times during the event.The lifevest detected asystole with cpr artifact at 03:12:57 and deployed gel.Between 03:19:27 and 03:21:39 the lifevest delivered five treatments during asystole with intermittent cardiac activity.The patient remained in asystole after the treatments.Cpr artifact and oversensing of small cardiac signal contributed to the false detections.At 03:22:14 the patient transitioned to an accelerated idioventricular rhythm.The lifevest delivered a sixth treatment at 03:22:44.Multiple counting of the accelerated idioventricular rhythm contributed to the false detection.The patient received two non-lifevest defibrillations at 03:23:18 and 03:23:53, and the patient remained in an idioventricular rhythm (100 bpm).The patient then degraded to asystole, and the lifevest delivered a seventh treatment at 03:27:59.Oversensing and cpr artifact contributed to the false detection.The lifevest delivered seven more treatments between 03:28:59 and 03:38:33 during periods of asystole and an accelerated idioventricular rhythm.The lifevest electrical belt was disconnected at 03:40:29.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5543944
• MDR Text Key: 41759012
• Report Number: 3008642652-2016-02136
• 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
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR