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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Over-Sensing (1438); Structural Problem (2506)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2024

Event Type  Injury  

Manufacturer Narrative

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 (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

The patient was inappropriately treated 1 time by the life vest.The patient was reportedly conscious at the time of the event.Motion artifact contributed to the false detection.The response buttons were pressed after the treatment was delivered.The response buttons functioned appropriately.The patient was driving a motorcycle at the time of the event.No injury was reported from the treatment.The patient went to the hospital for evaluation.The patient continued to use the lifevest.No deficiencies were alleged against the device.

Manufacturer Narrative

Device evaluation of electrode belt has been completed.The reported problem (unable to complete incoming testing) has been confirmed.Upon investigation the electrode belt trunk cable and dn to rear therapy electrode was severed, damaging all wires in the cable.The root cause for the severed cables was physical abuse.The device malfunction did not contribute to the adverse event.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 (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 reported that an electrode belt was unable to complete essential performance testing.The patient was inappropriately treated 1 time by the life vest.The patient was reportedly conscious at the time of the event.Motion artifact contributed to the false detection.The response buttons were pressed after the treatment was delivered.The response buttons functioned appropriately.The patient was driving a motorcycle at the time of the event.No injury was reported from the treatment.The patient went to the hospital for evaluation.The patient continued to use the life vest.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
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 18844452
• MDR Text Key: 336958045
• Report Number: 3008642652-2024-02560
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• 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