MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC WEVENT WIRELESS CARDIAC EVENT MONITOR

Model Number	900-0612-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sudden Cardiac Death (2510)
Date of Event	08/28/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Braemar manufacturing, llc has completed a preliminary evaluation of the returned device.The device was received at braemar manufacturing, llc eagan, mn on 09/06/2019.A device history record (dhr) review of the affected device indicated that this wevent er920w 3g cdma was originally shipped to the distributor on 02/14/2017.There is no history of factory service at braemar manufacturing, llc (eagan, mn).Production line and final test procedures were performed, with no failures identified.Engineering investigation of the device identified no device malfunction or failures that could have caused or contributed to the reported patient's death.This report is being submitted due to the initial reporter's notification of patient death while wearing the device.Additional evaluation activities are being performed by braemar manufacturing, llc.No additional information is known to braemar manufacturing, llc at this time.
Event or Problem Description
On 08/28/2019, m.D., director regional sales ((b)(6)) received a phone call from (b)(6) notifying of patient expiry.The patient was in a nursing facility (located in (b)(6)) and had been wearing the wevent monitor s/n (b)(4) for about three (3) days.The patient was found deceased overnight (found on (b)(6) 2019) while still wearing the device.The medical examiner removed the device and the nursing staff obtained it from the morgue.The device was returned to braemar manufacturing, llc on 09/06/2017 under rma r011745.The patient cause of death, if determined, is unknown to braemar manufacturing, llc and (b)(6).This report is being submitted due to notification of patient death while wearing the wevent monitor.The become aware date for braemar manufacturing, llc is 09/04/2019.

• Brand Name: WEVENT WIRELESS CARDIAC EVENT MONITOR
• Common Device Name: WEVENT WIRELESS CARDIAC EVENT MONITOR
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• MDR Report Key: 9134509
• Report Number: 2133409-2019-00012
• Device Sequence Number: 2782405
• Product Code: DSI
• UDI-Device Identifier: B146EP010
• UDI-Public: B146EP010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 900-0612-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 45 YR