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

Model Number	WEVENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to braemar for evaluation on 04/17/2018.It is believed the cause of the battery malfunction will most likely not be able to be determined due to the damage to the battery and device.Upon review of 2018 and 2017 complaints, this was the second reported event in 2018.Previous to 2018 there were three similar events reported to the fda via mdrs 2133409-2016-00002, 2133409-2016-00003, and 2133409-2017-00001.(b)(4).An evaluation will be performed with an external failure analysis expert, and a supplemental mdr will be submitted with any new results.Prior to this reported event in early 2018, braemar has begun transitioning to a new rechargeable battery option to reduce the likelihood of future battery rupture events.
Event or Problem Description
Braemar received information on 04/12/2018 from our distributor in which they reported an adverse incident involving one of the braemar er920w event recorders and a disposable lithium thionyl chloride battery.The distributor informed braemar a battery ruptured/exploded in the device in a patients home while the device was sitting on a table.No patient injury was reported.As the result of the review of photos received of the ruptured battery and resulting damage observed on the returned device, it was determined this event could be likely to cause or contribute to a serious event if it were to recur, and is therefore being reported to the fda per 21 cfr 803 as an mdr.
Additional 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.
Additional Manufacturer Narrative
Braemar manufacturing in no longer investigating this incident and consider this matter closed.
Event or Problem Description
(b)(6) contacted braemar manufacturing about a wevent device in which a lith battery ruptured in the device, in a patients home while the device was sitting on a table.No patient injury was reported.

• Brand Name: ER920W WIRELESS EVENT RECORDER
• Common Device Name: WEVENT
• Manufacturer (Section D): BRAEMAR MANUFACTURING LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• MDR Report Key: 7502965
• Report Number: 2133409-2018-00002
• Device Sequence Number: 11295322
• Product Code: MLO
• UDI-Device Identifier: B146ER9WCNC0
• UDI-Public: +B146ER9WCNC0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: WEVENT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 09/04/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 09/27/2018; 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1