MAUDE Adverse Event Report: BRAEMAR MANUFACTURING LLC ER920W EVENT RECORDER

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Cardionet provided the device to braemar on (b)(6) 2016.Since damage to the device has been confirmed braemar is treating this event as a reportable malfunction.At this time the cause is unknown.Investigation to determine a cause is underway.

Event Description

Braemar received information on 09/28/2016 from cardionet in which they reported a single use disposable lithium thionyl battery installed in a device exploded.The patient was not wearing the device when the incident occurred.No patient harm was reported.

Manufacturer Narrative

Braemar provided all the incident items to an external failure analysis expert for investigation.The investigation was inconclusive for the root cause of the failure, due to the severity of the damage to the battery.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: EVENT RECORDER
• Manufacturer (Section D): BRAEMAR MANUFACTURING LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: darren dershem ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6512868630
• MDR Report Key: 6058085
• MDR Text Key: 58817735
• Report Number: 2133409-2016-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1