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

Model Number ER920W

Device Problems No Display/Image (1183); Battery Problem (2885)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

Braemar received info on (b)(6) from (b)(6) in which they reported a potential adverse incident involving one of the braemar er920w event recorders and an ecardio supplied disposable lithium thionyl chloride battery pack.(b)(6) provided the device serial number along with the following statement on (b)(6)."we are currently in the process of discovering this unit and associated materials.To date, we haven't received much info on this one.Pt complained about a screen malfunction and battery drain prior to the incident, so we directed pt to remove the monitor and shipped her another.Pt continued to wear the first monitor and was wearing it at night in bed when the reported incident occurred.They provided two unidentifiable pictures of a torso with skin damage, but we don't have any doctor reports or pt statements to support the pictures.".

Manufacturer Narrative

Based on the info provided braemar is treating this as a reportable event.Braemar has been informed by (b)(4) that they are distributing batteries that were not recommended by the mfr, contrary to the labeling.Braemar is unable to determine, at this time, whether the installation of non-mfr recommended batteries caused or contributed to the event.Because braemar has not been provided with additional details regarding the event, info regarding the pt's status, or the device for analysis, the company is unable to determine a cause.Braemar has requested further details about the pt injury claim, the device and original (b)(4) supplied battery pack as well as any accessories for further investigation.

Manufacturer Narrative

Braemar over several months made numerous requests to have the device returned.Preventice (formerly ecardio) has not returned the device.

• Brand Name: ER920W EVENT RECORDER
• Type of Device: DRG, MLO
• Manufacturer (Section D): BRAEMAR MFG, LLC; eagan MN
• Manufacturer Contact: darren dershem ; 1285 corporate center dr.; suite 150; eagan, MN 55121 ; 6512868620
• MDR Report Key: 3810653
• MDR Text Key: 4386220
• Report Number: 2133409-2014-00004
• 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,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• 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?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1