MAUDE Adverse Event Report: BRAEMAR MANUFACTURING LLC. ER920W; EVENT RECORDER

Model Number WEVENT

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) provided the incident battery and device to braemar on 06/15/2017.Since damage to the device has been confirmed braemar is treating this issue as a reportable malfunction.The cause is unknown at this time.The investigation is on-going at this time.

Event Description

A single use disposable lithium thionyl chloride battery was inserted into a device returned from the field, to our customer's distribution facility, to move the device through their check-in process.A battery cell separated while the device was powered.No report of injury was received.

Manufacturer Narrative

Braemar provided all the incident items to an external failure analysis expert for investigation.The investigation determined some regions of the internal negative cell tab had the appearance of melting, possibly due to an internal electrical fault.The investigation was inconclusive for the root cause of the failure, due to the severity of the damage to the battery.

• Brand Name: ER920W
• 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 ; 6512868620
• MDR Report Key: 6694970
• MDR Text Key: 79599304
• Report Number: 2133409-2017-00001
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WEVENT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1