MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

Model Number WCD 4000

Device Problem Improper Chemical Reaction (2952)

Patient Problems Abrasion (1689); Allergic reaction (1701); Blister(s) (1743)

Event Date 05/02/2014

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.On (b)(6) 2014 a zoll territory mgr (tm) contacted zoll customer support to report that a (b)(6) female pt had a rash.During a follow up with the pt the pt reported having lesions, blood blisters and regular blisters.She stated that her whole upper body was covered in a rash and she had sores.The pt reported that she spoke to her cardiologist and he determined that she was allergic to the metals in the life vest.The pt ended use of the lifevest.It is unk whether the pt required med intervention.The clinical outcome of the skin irritation is unk.

Manufacturer Narrative

Electrode belt sn (b)(4) was not returned for the event investigation.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
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: allison petzold ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4261808
• MDR Text Key: 17261567
• Report Number: 3008642652-2014-04026
• 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,Company Representative
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• 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
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR