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

Model Number WCD 3100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Allergic reaction (1701)

Event Date 10/23/2013

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.A nurse from a (b)(6) year old male patient's doctor office contacted zoll to report that the patient had an allergic reaction to the electrodes.One of the electrodes had created a red swollen area that was oozing.The doctor instructed the patient to move the garment a little bit to the side so the electrodes would not be on the same red swollen spots.However, the same thing happened to the new area of skin where the electrodes were moved to.A patient service representative (psr) was sent to follow up with patient two days later.The psr stated that the patient's skin under the right electrode is breaking down.The patient's wife moved the electrode to a different spot and the skin under the new area then also started to break down.There was no follow up on the skin break down 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: 4257313
• MDR Text Key: 21490661
• Report Number: 3008642652-2014-03877
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2014

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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: 78 YR