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

Model Number WCD 3100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/03/2009

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) female patient contacted zoll customer support to report a bright red rash on her back.The patient is concerned that the rash may be a bacterial infection.The patient contacted zoll customer support on(b)(6) 2009 inquiring about delivery of her "hypoallergenic" therapy pads.Support told the patient that there is only one type of therapy pad available.Patient f/u on (b)(6) 2009 reporting that she is five months pregnant, and her physician had her temporarily remove the lifevest due to the allergic reaction until the baby is born.There was no additional f/u on the alleged bacterial infection or the allergic reaction.

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: dianna stuckey ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4257288
• MDR Text Key: 21877616
• Report Number: 3008642652-2014-03725
• 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

• Date FDA Received: 11/12/2014
• 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?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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: 31 YR