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

Model Number WCD 4000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Arrhythmia (1721)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

There is no indication of a device malfunction contributing to the adverse event.

Event Description

The patient's nurse reported that the patient was cardioverted while in vt.It was found that the device was not active when this cardioversion took place, therefore there is no record of this event.The battery was reportedly removed, it is unclear who removed the battery.Per clinical review of the downloaded data, the device started up at 13:15:02 on (b)(6) 2019.The device detected an arrhythmia at 14:47:13, while the patient's heart rhythm was a sinus rhythm at 75 bpm with pvc's transitioning to vt at 150bpm.The patient's physician prescribed treatment threshold for vt is 150 bpm.The response buttons were pressed intermittently between 14:47:22 and 14:54:38 and the patient entered a non-treatable rhythm at 14:55:11.It is unclear who pressed the response buttons.The response buttons functioned appropriately.The device detected another arrhythmia at 14:55:14, while the patient was in vt at 150 bpm.The response buttons were pressed intermittently between 14:55:48 and 15:01:29 and the patient entered a non-treatable rhythm at 15:01:40.It is unclear who pressed the response buttons.The response buttons functioned appropriately.The device was shutdown at 15:01:41 on (b)(6) 2019.Although the patient was in vt at his physician prescribed treatment threshold the response button usage stopped a treatment from occurring.The patient remained in the hospital after the event and continues to wear the lifevest.It was reported that the patient will be receiving an icd soon.The patient reported no adverse events and no allegations were made against the lifevest.As it is unclear as to who was pressing the response buttons and who removed the battery, reporting out of an abundance of caution.

• 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8587712
• MDR Text Key: 144398373
• Report Number: 3008642652-2019-02964
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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?: Yes
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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): Other
• Patient Age: 78 YR