MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 3100 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 3100

Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 12/10/2010

Event Type  Death  

Event Description

During a retroactive review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.On (b)(6) 2010, (b)(6) male patient's nurse contacted zoll and reported that the lifevest was 'alarming and saying do not touch patient but never fired' and that 'staff say patient was in vt on their telemetry'.

Manufacturer Narrative

Device evaluations of monitor sn (b)(4) and belt sn (b)(4) were completed.Upon evaluation, the monitor and electrode belt were fully functional.The pt reportedly passed away (b)(6) 2010.The time of death is unk.Zoll analysis indicates a treatment was delivered (b)(6) 2010 at 03:29:52am.Review of the ecg recording reveals an episode of sustained vt/vf, which was appropriately detected.However, about six seconds prior to the treatment, it appears that the lifevest was being removed from the pt, resulting in a 0j pulse energy.Belt: 10/2008.

• Brand Name: LIFEVEST WCD 3100 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4250077
• MDR Text Key: 21932579
• Report Number: 3008642652-2014-03589
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 3100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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