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

Model Number ER920W

Device Problems Battery Problem (2885); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Braemar received info on (b)(6) 2014 from ecardio in which they received a report from a patients parent for what was described as some type of device explosion.The patient was not wearing the monitor and there was no report of any injury.

Manufacturer Narrative

Ecardio provided the device as well as accessories to braemar on (b)(4) 2014.Since damage to 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 under way.

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.The failure analysis expert determined that a portion of the negative current collector tab within the battery appeared rounded and slightly thickened, which is consistent with melting and re-solidification of metal, and could be due to an arcing/shorting event.The observed failure mode involving the cell negative current collector tab is similar to the failure mode observed on previous mdr 2133409-2014-00003.Braemar is in the process of taking corrective action with the battery manufacturer.

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, INC.; eagan MN
• Manufacturer Contact: darren dershem ; 1285 corporate center dr.; suite 150; eagan, MN 55121 ; 6512868620
• MDR Report Key: 4384464
• MDR Text Key: 5369039
• Report Number: 2133409-2015-00001
• 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: Other,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• 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: 12/31/2014
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1