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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING LLC ER920W EVENT RECORDER

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BRAEMAR MANUFACTURING LLC ER920W EVENT RECORDER Back to Search Results
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.
 
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Brand NameER920W EVENT RECORDER
Type of DeviceEVENT 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
MDR Report Key7245554
MDR Text Key99802359
Report Number2133409-2018-00001
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWEVENT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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