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

Model Number ER920W

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Braemar was provided digital pictures of the device from cardionet, showing damage to the device consistent with a reportable malfunction.At this time the cause is unkown.Waiting on return of device.

Event Description

Braemar recieved information on (b)(6) 2015 from cardionet in which they reported a battery installed into a braemar event recorder exploded in a patient's home.The patient was not wearing the monitor at the time.No patient injury was reported.

Manufacturer Narrative

Braemar received the device for evaluation on 1/14/16.The single use disposable batteries were not returned.The distributor has confirmed they accidently disposed of the batteries as well as other device items.Braemar did perform a visual evaluation of the device but without the batteries could not determine a cause.The cause is unknown.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: EVENT RECORDER
• Manufacturer (Section D): BRAEMAR MANFUACTURING, 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: 5258725
• MDR Text Key: 32762641
• Report Number: 2133409-2015-00005
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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