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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Device Sensing Problem (2917)

Patient Problems Dizziness (2194); Shock from Patient Lead(s) (3162)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The monitor sn (b)(4) and electrode belt sn (b)(4) have not been returned for evaluation.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the inappropriate treatment.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 g960083 (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

The patient was inappropriately treated one time by the lifevest.The patient was reportedly conscious at the time of the event but felt lightheaded.Motion artifact contributed to the false detection.The response buttons were not pressed during the event.No injury was reported from the treatment.The patient went to the emergency room for evaluation.The patient continued to use the lifevest.No deficiencies were alleged against the device.

• 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: shannon mclane ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11556026
• MDR Text Key: 241846239
• Report Number: 3008642652-2021-02633
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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