MAUDE Adverse Event Report: BRAEMAR MANUFACTURING LLC ER920W EVENT RECORDER

Model Number WEVENT

Device Problem Material Rupture (1546)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Although the device has not yet been returned for evaluation, 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 shown in the photo's provided.Upon review of 2018 and 2017 complaints, this was the first reported event in 2018.Previous to 2018 there were two similar events reported to the fda via mdrs 2133409-2016-00002 and this report.(b)(4).Upon return of the device associated with this event, 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, braemar implemented in early 2018 the option to utilize rechargeable batteries that are less prone to rupture to further reduce the potential for future events to occur.

Event Description

Braemar received information on 01/08/2018 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.The patient was not wearing the device at the time, and no patient injury was reported.As the result of the review of photos received of the ruptured battery and resulting damage to the 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.

Manufacturer Narrative

Multiple unsuccessful requests for return of the incident battery and device were made.Braemar cannot take further action at this time since the items have not been returned.

• 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
• MDR Report Key: 7245554
• MDR Text Key: 99802359
• Report Number: 2133409-2018-00001
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K072008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1