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

Model Number WCD 4000

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 12/14/2014

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a (b)(6) male pt passed away on (b)(6) 2014 in hospice.Downloaded data shows that between 23:45:12 and 23:47:54 on (b)(6) 2014, the pt was in bradycardia at 50 bpm transitioning to ventricular fibrillation (vf) and then to asystole.The lifevest did not treat the pt due to electrode fall off, varying amplitude, and the heart rate falling below the threshold for treatment.There were no alleged deficiencies against the lifevest.

Manufacturer Narrative

Device evaluation summary: device evaluation of electrode belt (b)(4) is complete.As received, the electrode belt was fully functional and able to detect and treat.Device evaluation of monitor sn (b)(4) is currently underway.A supplemental report will be submitted upon completion of the device evaluation.At this time, there is no information to reasonably suggest that the lifevest caused or contributed to the pt death.Monitor (b)(4): 06/2011 - reuse, electrode belt (b)(4): 12/2013 - reuse.Review of the data does not indicate any device malfunction related to the pt death.There is no information to reasonably suggest that the device caused or contributed to the pt's death.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) was completed.There is no indication of any monitor malfunction contributing to the patient death.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.There is no indication of a product malfunction.Device evaluation of electrode belt (b)(4) is complete.As received, the electrode belt was fully functional and able to detect and treat.Review of the data does not indicate any device malfunction related to the patient death.There is no information to reasonably suggest that the device caused or contributed to the patient's death.

Event Description

A us distributor contacted zoll to report that a (b)(6) male patient passed away on (b)(6) 2014 in hospice.Downloaded data shows that between 23:45:12 and 23:47:54 on (b)(6) 2014, the patient was in bradycardia at 50 bpm transitioning to ventricular fibrillation (vf) and then to asystole.The lifevest did not treat the patient due to electrode fall off, varying amplitude, and the heart rate falling below the threshold for treatment.There were no alleged deficiencies against the lifevest.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4524867
• MDR Text Key: 5405740
• Report Number: 3008642652-2015-00692
• Device Sequence Number: 1
• Product Code: MVK
• 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,distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2011
• 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): Death
• Patient Age: 68 YR