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

Model Number WCD 4000

Device Problems Thermal Decomposition of Device (1071); Noise, Audible (3273)

Patient Problems Headache (1880); Pain (1994); Shock (2072)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

There was no death or serious injury associated with the alleged event.Device evaluation summary: device evaluation of monitor sn (b)(4) has been completed.The reported problem (won't power on) has been confirmed.Upon investigation the monitor was unable to power on.The cause for the failure was isolated to the defibrillator pca and computer/analog board.High voltage travelled to low voltage circuitry, damaging multiple components on the pcas.The root cause for the high voltage travelling to low voltage circuitry could not be positively identified.Device evaluation of electrode belt sn (b)(4).Has been completed.The reported problem (patient treatment) was unable to be confirmed.Upon investigation, the electrode belt was unable to communicate with a monitor.The cause for the failure was isolated to a thermally damaged esd700 diode array on the distribution node pca.The root cause for the shorted diode array could not be positively identified.Additional inappropriate defibrillation narrative: the primary cause of the shock event is unknown due to the loss of ecg and flag data.The primary cause of the detection is unknown due to the loss of ecg data.Unable to confirm any treatment delivery.

Event Description

A u.S distributor contacted zoll to report that a patient experienced a defibrillation event on (b)(6) 2019.The patient reported that she had been treated by the lifevest on (b)(6) 2019 at approximately 11:15 pm.The patient reported that she "heard a snap and then felt a horrible pain that shot through her and caused a headache and jaw pain".The patient reported that she did not have blue gel on her.There is no evidence that the patient was treated.The download data, from the days surrounding of the alleged event, does not show any automatic events or flags indicating that a treatment or gel deployment occurred.Based on the available information, there is no indication of a treatment event.There is no indication of medical intervention.There is no indication of serious injury.Following the alleged treatment, the patient did not seek medical intervention and continued wearing the lifevest.The ecg and flag data surrounding the alleged treatment was unavailable for review due to thermal damage within the monitor.The occurrence of treatment is unable to be confirmed.This event is being reported out of an abundance of caution as zoll is unable to positively determine if the defibrillation treatment occurred and if it was appropriate or inappropriate.There was no death or serious injury associated with the alleged defibrillation event.

• 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: 8457150
• MDR Text Key: 140119302
• Report Number: 3008642652-2019-02214
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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: 02/27/2019
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• 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: 67 YR