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

Model Number ER920W

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

Patient Problems Scar Tissue (2060); Burn, Thermal (2530); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

Braemar understands that the patient was seen in an emergency room following the event.Braemar has requested details regarding the nature and seriousness of the patient injury from preventive solutions group preventive solutions group provided the device to braemar on (b)(4) 2015.Braemar visually inspected the device but could not determine a cause.At this time a cause is unknown.Investigation to determine a cause is underway.

Event Description

Braemar received information on (b)(4) 2015 from (b)(6) in which they reported an adverse incident involving one of the braemar er920w event recorders.On (b)(6) 2015 preventice solutions group received a phone call from a patient who told them the er920w device he was wearing exploded.

Manufacturer Narrative

(b)(4) provided information the patient was treated in an emergency room for cuts and burns from the incident.The patient was treated and released with medication for the burns and did not have to follow up with a physician.Braemar provided all the incident items to an external failure analysis expert for investigation.The investigation was inconclusive for the root cause of the failure.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: EVENT RECORDER, 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: 5060319
• MDR Text Key: 25653753
• Report Number: 2133409-2015-00004
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/27/2015
• Initial Date Manufacturer Received: 08/05/2015
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 84 YR