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

Model Number WCD 4000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Abrasion (1689); Allergic reaction (1701)

Event Date 01/20/2012

Event Type  Injury  

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.The son of a (b)(6) year old female patient contacted zoll customer support to report that the patient is developing red, oozing sores under all four electrodes.The patient has had a severe metal allergy since childhood.Follow-up on (b)(6) 2012 with the patient's son indicates, the patient still has a skin irritation, and the son had spoken with the patient's doctor.The patient's son reports that the patient cannot continue to wear the lifevest.Patient ended use.

Manufacturer Narrative

Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue defibrillation gel.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: dianna stuckey ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4257245
• MDR Text Key: 19968331
• Report Number: 3008642652-2014-03765
• 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: Other
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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): Other
• Patient Age: 77 YR