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

Model Number WCD 3100

Device Problem Insufficient Information (3190)

Patient Problem Allergic reaction (1701)

Event Date 06/10/2013

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 wife of a (b)(6) male contacted zoll to report that her husband had broken out in a horrible rash all over his upper body.The pt's wife asked if it was possible that it is an allergic reaction to the lifevest.The pt had what appeared to be welts all over his upper body.The pt's wife insinuated that the rash be an allergic reaction to some new medication the pt was just put on.The pt's wife said that they have tried to contact the doctor, but haven't been able to reach anyone.Technical support follow up with the patient two days later.The pt's wife said that the pt went to the doctor's the day before.The nurse practitioner said the rash was likely due to his medication because the rash was all over the pt's body and not just on his torso.The pt was given a new medication and steroids to help with the reaction.The pt's wife said that the rash has already started to improved.

Manufacturer Narrative

Device evaluation summary: biocompatibility test to iso 10993 was successfully completed on skin-contacting surface of the lifevest device as well as the blue 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: 4262123
• MDR Text Key: 15124455
• Report Number: 3008642652-2014-03938
• 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: 11/11/2014

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 3100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2014
• 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: 70 YR