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 06/12/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, 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 tactile vibration alarm, 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.

Event Description

A us distributor contacted zoll and reported that the patient passed away on (b)(6) at 03:21am at a rehabilitation facility while wearing the lifevest.The patient was reportedly unconscious and the facility staff initiated resuscitation efforts.Ems was called and it was reported that they may have cut the device off of the patient.Device download data revealed that the patient was treated eight times during the event.At 00:43:36, the patient degraded from sinus rhythm at 80 bpm to polymorphic vf degrading to asystole with intermittent cardiac activity.Between 00:45:39 to 02:35:53, the device continued detecting asystole with intermittent cardiac activity and cpr artifact.At 02:36:50, the device released gel.Between 02:37:02 and 03:05:29 the lifevest delivered eight treatments during asystole with cpr artifact.The seventh and eight treatment shocks were low energy at 115j and 119j respectively.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.The cpr artifact contributed to the false detections.The patient remained in asystole during the treatments.The lifevest electrode belt was disconnected at 03:33:21.There is no indication that the lifevest treatments during asystole caused or contributed to the death, as the patient was already in a non-life-sustaining rhythm prior to the treatments.No deficiencies were alleged against the lifevest.

• 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 Key: 7715744
• MDR Text Key: 114894129
• Report Number: 3008642652-2018-06443
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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: 06/26/2018
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• 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: 53 YR