FDA Adverse Event
Malfunction
Summary report: N
WEVENT WIRELESS CARDIAC EVENT MONITOR
MDR report key: 8620893
·
Received May 17, 2019
Report
- Report Number
- 2133409-2019-00004
- Event Type
- Malfunction
- Date Received
- May 17, 2019
- Date of Event
- April 1, 2019
- Report Date
- May 17, 2019
- Manufacturer
- BRAEMAR MANUFACTURING, LLC
- Product Code
- DSI
- PMA / PMN Number
- K072008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BRAEMAR MANUFACTURING, LLC HAS NOT RECEIVED THE AFFECTED DEVICE BACK FOR EVALUATION AT THE TIME OF THIS SUBMISSION. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.
Description of Event or Problem · 1
ON (B)(6) 2019, THE INITIAL REPORTER (DISTRIBUTOR AGENT) NOTIFIED BRAEMAR MANUFACTURING, LLC OF A REPORT OF THE DEVICE BATTERIES POPPING. THE PATIENT'S SPOUSE NOTIFIED THAT THE BATTERIES POPPED AND SHOT ACROSS THE ROOM, RESULTING IN SMOKE. NOTE: THE ACTUAL DATE IS UNKNOWN AND WAS REPORTED TO THE DISTRIBUTOR ON (B)(6) 2019. BRAEMAR MANUFACTURING, LLC'S BECOME AWARE DATE IS 18-APR-2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413775 | WEVENT WIRELESS CARDIAC EVENT MONITOR | WIRELESS CARDIAC EVENT MONITOR | DSI | BRAEMAR MANUFACTURING, LLC | 900-0612-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |