MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WEARABLE DEFIBRILLATOR; WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR

Device Problems Defibrillation/Stimulation Problem (1573); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

Life vest would work for 10-30 minutes then start alarming "poor connection".Did this several times.Staff called zoll customer support.Tried trouble shooting.Nothing helped.

• Brand Name: LIFEVEST WEARABLE DEFIBRILLATOR
• Type of Device: WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• MDR Report Key: 15825058
• MDR Text Key: 303922161
• Report Number: 15825058
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Male