MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC ER920W EVENT RECORDER

Model Number ER920W

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

Braemar received info on 03/25/2015 from cardionet in which they reported a battery installed into a braemar event recorder exploded at their facility.This incident occurred overnight while no one was in the facility.

Manufacturer Narrative

Cardionet provided digital photographs that show extensive damage to the device.Cardionet provided the device to braemar on 03/30/2015.Since damage to the device has been confirmed, braemar is treating this event as a reportable malfunction.At this time, the cause is unk.Investigation to determine a cause is underway.

Manufacturer Narrative

Braemar provided all the incident items to an external failure analysis expert for review.The root cause of the failure was not determined, due to the damage severity of the items.

• Brand Name: ER920W EVENT RECORDER
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; eagan MN
• Manufacturer Contact: darren dershem ; 1285 corporate center dr.; suite 150; eagan, MN 55121 ; 6512868620
• MDR Report Key: 4729804
• MDR Text Key: 5585530
• Report Number: 2133409-2015-00002
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ER920W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1