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 Problem Dizziness (2194)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

Monitor sn (b)(4) was returned to the distributor for evaluation.The sd card fault was confirmed and the sd card was found to be defective, preventing the ecg data from being downloaded.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.The root caues of the defective sd card could not be positively identified.There is no indication of a product malfunction that would contribute to the patient treatment.Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (patient treatment) has been confirmed.All gels were deployed.Upon investigation the electrode belt was unable to properly communicate with a monitor.The cause for the failure was isolated to shorted esd700 diode array on the distribution node pca.A root cause investigation determined that conductive gel from the therapy electrodes ingressed into the therapy electrode enclosure, causing a short on the therapy electrode pca and damaging the eds700 diode array on the distribution node pca.Manufacture dates: monitor - 07151399 - 01/30/2016.Belt - 59151859 - 02/26/2016.

Event Description

A us distributor contacted zoll to report that a patient was treated by the lifevest.The patient reported that they were outside raking leaves when they heard a pop and felt a shock.The patient did not recall hearing any alarms.The patient was reportedly conscious and asymptomatic before the treatment delivery and felt dizzy after the shock.Review of the patient's downloaded flag files revealed that one treatment shock was delivered to the patient.The shock occurred on (b)(6) 2019 at 3:05:35 pm.Due to an sd card fault, the patient's ecg rhythms at the time of the treatments is unknown.The response buttons were pressed intermittently during the event, but not immediately prior to the treatment delivery.The response buttons were found to be fully functional.The patient reportedly received medical attention at a hospital and continues to wear the lifevest.As the appropriateness of the treatments is unknown, reporting this event out of an abundance of caution.Additionally, during the investigation of the electrode belt associated with this treatment event, a reportable malfunction was found.

• 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: eliza schally ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 9601159
• MDR Text Key: 188886655
• Report Number: 3008642652-2020-00430
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: 12/20/2019
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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): Hospitalization; Other
• Patient Age: 47 YR