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

Model Number ER920W

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) provided the device at braemar on 08/07/2015.Since damage to the device has been confirmed braemar is treating this event as a reportable malfunction.Braemar visually inspected the device but could not determine the cause.At this time the cause is unk.Investigation to determine a cause is underway.

Event Description

Braemar received info on (b)(6) 2015 from (b)(4) in which they reported a battery installed ito a braemar event recorder exploded in a pt's home.The pt was not wearing the monitor at the time.No pt injury was reported.

Manufacturer Narrative

Braemar provided all the incident items to an external analysis expert for review.The root cause of the failure was not determined, due to the damage severity of the items.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: EVENT RECORDER
• 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: 5052714
• MDR Text Key: 25521151
• Report Number: 2133409-2015-00003
• 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: Followup
• Report Date: 08/03/2015

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: 08/07/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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