MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC ER920W EVENT RECORDER; DRG, MLO

Model Number ER920W

Device Problems Split (2537); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Braemar received information on (b)(4) 2014 from (b)(6) in which they reported receiving one braemar er920w event recorder inside a shipping package with a braemar supplied battery pack with that appears to be a partially split battery.The er920w event recorder appears to have a thermally damaged battery compartment area.

Manufacturer Narrative

(b)(6) provided the device as well as accessories to braemar on (b)(4) 2014.Since a partially split disposable lithium thionyl chloride battery and thermal damage to the battery compartment area of the device has been confirmed braemar is treating this event as a reportable malfunction.At this time the cause is unk.Investigation to determine a cause is underway.

Manufacturer Narrative

Braemar performed a visual inspection of the returned device and accessories but could not determine a cause.Braemar provided all the incident items to an external failure analysis expert for review.Initially the expert could not find a cause.The scope of the failure analysis investigation was then expanded to include some additional disposable battery packs returned from the field with similar discoloration evidence of thermal heating.Based on these add'l samples the failure analysis expert was able to determine that the negative current collector within the battery had made contact with positive material causing an internal short and heat.On 05/08/2015 the failure analysis expert confirmed this same issue existed in the original incident cell associated with this original mdr filing.Braemar is in the process of taking corrective action with the battery mfr.

Manufacturer Narrative

The external failure analysis expert investigation determined that an area of the negative current collector at the point of required 90° bend made contact with the positive material.The battery manufacturer investigated this reported information and determined possible workmanship issues with the flattening of the negative current collector within the cell.This step may have been missed or improperly performed.Corrective action was taken by the battery manufacturer.The manufacturer has implemented improved process control steps with this operation.However, due to the required 90° bend of the negative current collector this section will always be an area with slightly thicker material and will have the potential to have metal burrs present due to the machining operation.To mitigate the possibility of an internal short, due to penetration of burrs on the negative current collector, an additional layer of 0.2mm thickness glass fiber insulation was added to the 90° bend area.These battery improvements were released as revision-b of the braemar battery part number 350-0294-02.At the time of release no further shipments of the previous revision-a batteries were occurring.As part of additional investigation into the battery improvements, braemar had external failure experts confirm the existence and placement of the additional glass fiber layer on a random revision-b battery sample.In addition external failure experts conducted testing to expose the revision-b battery to extreme external short circuit conditions of 0.003 ohms at temperatures of -22°f, +70°f, +104°f and +122°f.The intent of these tests was to expose the battery to abusive conditions.No battery failures occurred in the 90° bend area of the negative current collector.In conclusion, failure analysis determined the issue with the 90° bend.The manufacturer implemented process control steps and added the glass fiber insulation.Failure analysis then confirmed the existence and placement of the glass fiber insulation on the revision-b battery.Additional failure analysis confirmed no battery failures occurred in the 90° bend area during extreme short circuit conditions.Braemar has received no field incident reports regarding the revision-b battery.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: DRG, MLO
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; eagan MN
• Manufacturer Contact: darren dershem ; 1285 corporate center dr.; suite 150; eagan, MN 55121 ; 6512868620
• MDR Report Key: 3834633
• MDR Text Key: 20655865
• Report Number: 2133409-2014-00003
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ER920W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1