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

Model Number WCD 3100

Device Problem Insufficient Information (3190)

Patient Problems Allergic reaction (1701); Unspecified Infection (1930)

Event Date 08/02/2012

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.A (b)(6) year old male patient called into zoll to report that he has a rash under the front therapy electrode pad.The patient wanted to know what materials the lifevest was made of.Technical support told the patient that the device has stainless steel therapy electrode pads and the netting on the garment is made of (b)(4).The patient put a nurse from the dermatologist on the phone.The nurse said that she thinks the rash is an allergic reaction due to something in the device.According to the nurse, the patient only has irritation on his front side and no irritation on his back.The nurse said that she also thinks it may be a staph infection and that the dermatologist is testing the rash.There was no follow up on rash to see if it healed.

Manufacturer Narrative

Device evaluation summary: biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue (tm) defibrillation gel.

• Brand Name: LIFEVEST WCD 3100 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: nina rudolph ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4257265
• MDR Text Key: 15327056
• Report Number: 3008642652-2014-03801
• 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: 11/07/2014

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 3100
• 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
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR