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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Vomiting (2144); Dizziness (2194); Shock from Patient Lead(s) (3162)

Event Date 08/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) has been completed.The reported problem (reset at pulse delivery) was confirmed.Review of the event indicates that the monitor reset at pulse delivery.The root cause for the resets was isolated to noise originating from the defibrillator pca high-voltage capacitors and propagating on the main battery wire on the monitor c/a board.There is no indication that the resets affected pulse delivery as each of the three shocks delivered were able to convert the arrhythmias.

Event Description

A us distributor contacted zoll to report that a patient may have been treated.The patient reportedly visited the emergency room after an episode where he was dizzy and vomiting.The patient reported that the device was alarming during this time.Review of the download data indicates that the patient entered bradycardia at 20bpm transitioning to vt at 260bpm and degrading to vf.Gel was released from the therapy electrodes and the device appeared to deliver a shock at this time which converted the arrhythmia to bradycardia at 30bpm.The device reset at this time.Approximately 20 minutes later, the patient's rhythm again transitioned to vt at 270bpm and degraded to vf and the device again appeared to deliver a shock which converted the arrhythmia to sinus bradycardia at 30bpm.The device again reset at this time.Approximately 10 minutes later, the patient's rhythm again transitioned to vt at 280bpm and the device again appeared to delivered a shock which converted the arrhythmia to bradycardia at 50bpm.The device again reset at this time.Approximately two minutes later, the patient's rhythm transitioned to sinus rhythm at 90bpm.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 9125105
• MDR Text Key: 166590248
• Report Number: 3008642652-2019-07773
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• 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