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

Model Number WEVENT

Device Problem Overheating of Device (1437)

Patient Problem Fall (1848)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Cardionet provided the device along with the single use disposable lithium thionyl battery involved in the event to braemar on 12/6/2016.Since the devices shows evidence of thermal heating, in which the devices plastic case shows signs of melting, braemar is treating this event as a reportable malfunction.The cause is unknown at this time.The investigation is on-going at this time.

Event Description

Braemar received information on 11/21/2016 from cardionet in which a patient reported an er920w device got hot while wearing it.The patient felt the device getting hot on their chest and quickly removed the device.The patient was not injured by the device heating in itself but was startled and did report tripping and falling upon standing up.We do not know if any injury occurred and are requesting more details.

Manufacturer Narrative

Braemar provided the incident device and lithium thionyl batteries to external failure analysis experts for investigation.The failure analysis experts determined that the batteries did not cause the incident since they were intact and did not vent and voltage measurements were normal.The failure analysis experts also determined internal damage to the device such as melted copper appeared to come from an external source.The failure analysis experts were able to reproduce very similar damage to a representative sample of a device and lithium thionyl batteries by heating the device and batteries inside of a microwave oven.Braemar does not know whether the original incident device was actually placed into a microwave oven nor are we able confirm or deny the original incident claims made by the patient.Based on the opinion of the external failure experts the device and lithium thionyl batteries were not the cause for this incident.

• 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
• Manufacturer Contact: darren dershem ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6512868620
• MDR Report Key: 6190597
• MDR Text Key: 63319968
• Report Number: 2133409-2016-00003
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR