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

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem No Code Available (3191)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

There was no death associated with the defibrillation event.Device evaluation summary: monitor sn (b)(4) was returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction.The distributor functionality testing confirmed that the device was fully functional.The monitor pulse delivery and ecg acquisition circuitry was fully functional.The electrode belt was returned to the distributor for evaluation.As received, all gels had been deployed.A visual inspection did not note any nonconformances.Review of the download software flag files on the day of the event was performed to determine whether there was an electrode belt malfunction.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the treatment event.There is no indication of an electrode belt malfunction.Device manufacture date: monitor: 04/23/2013.Belt: 07/04/2011.

Event Description

A us distributor contacted zoll to report that a patient received an appropriate treatment event consisting of six lifevest treatment shocks.The patient was reportedly at home at the time of the first treatment.It was reported that the patient was conscious and pressing the response buttons at the time of the first shock.Following the first treatment, ems was called and the patient was transported to the hospital.It was reported that the patient was defibrillated by hospital staff in the er.The lifevest detected an arrhythmia at 07:13:13 on (b)(4) 2018.The patient's rhythm was vt.The response buttons were pressed from 07:13:32 to 07:14:27, delaying treatment.The first shock was delivered at 07:15:16.Following the shock, the patient remained in vt and continued to press the response buttons, delaying treatment until a non-treatable rhythm was detected.The lifevest detected another arrhythmia at 08:35:15.The patient's rhythm was vt.The response buttons were pressed from 08:35:28 to 08:35:31, delaying treatment.Five shocks were delivered between 08:37:06 and 08:38:32 while the patient was in vt at 180 bpm.Following the sixth and final shock, the patient remained in vt.A subsequent treatment was not delivered due to the patient receiving the maximum 5 shocks in a single treatment sequence.At 08:40:17, after the sixth treatment, the electrode belt was disconnected.The lifevest functioned as designed, but was unable to convert the patient's arrhythmia.There was no death associated with this treatment 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: gabrielle salazar ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7306011
• MDR Text Key: 101269078
• Report Number: 3008642652-2018-02072
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2011
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR