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

Model Number WCD 4000

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Death (1802); Bone Fracture(s) (1870); Burn, Thermal (2530); Shock from Patient Lead(s) (3162)

Event Date 08/30/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: monitor sn (b)(4) and electrode belt sn (b)(4) have been returned to zoll manufacturing corporation, but have not been evaluated yet.Device evaluation included review of downloaded software flag files on the day of the event.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 inappropriate treatment.Treatment event analysis concludes: the patient received five inappropriate shocks.Amplitude oversensing and multiple counting contributed to the false detections.The response buttons were not pressed during the event.Patient's death was reported on (b)(6) 2020.Additional inappropriate defibrillation narrative: inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69% per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The lifevest detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.

Event Description

A us distributor contacted zoll to report that a (b)(6) patient passed away while wearing the lifevest on (b)(6) 2020.The patient was sedated in the hospital at the time of passing.Review of the download data indicates the patient received five inappropriate shocks on (b)(6) 2020 in response to amplitude oversensing and multiple counting.The patient was in sinus rhythm at 80-90 bpm at the time of each of the five shocks at 20:18:54, 20:27:37, 20:39:41, 20:41:30, and 20:45:19.The post shock rhythm for each shock was sinus rhythm at 80-90 bpm.The response buttons were not pressed during the treatment event.It was reported that the patient was terminally ill and rejected any life-prolonging measurements.After the patient received the treatments, it was reported that the treatments caused the patient to get fractured ribs and burned skin.There is no indication the alleged injury lead to a serious deterioration in the health of the patient, as the patient was reported to be terminally ill prior to the treatments.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 10686455
• MDR Text Key: 211562926
• Report Number: 3008642652-2020-08954
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): Y
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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; Hospitalization; Other
• Patient Age: 74 YR