FDA Adverse Event
Death
Summary report: N
BENEVISION TM80 TELEMETRY MONITOR
MDR report key: 11720932
·
Received April 23, 2021
Report
- Report Number
- 3009156722-2021-00006
- Event Type
- Death
- Date Received
- April 23, 2021
- Date of Event
- March 19, 2021
- Report Date
- March 24, 2021
- Manufacturer
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
- Product Code
- MSX
- PMA / PMN Number
- K193391
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RELATED SYSTEM LOG FILES WERE ANALYZED AND THE PVC/MIN ALARM WAS SET TO "OFF" DURING THE TIME OF THE REPORT. NO PRODUCT RELATED MALFUNCTION OCCURRED.
Description of Event or Problem · 1
A PATIENT BEING MONITORED ON A BENEVISION TM80 TELEPACK AND WAS REPORTED TO HAVE BEEN EXPERIENCING ATRIAL FIBRILLATION. SOMETIME AFTER, THE ECG WAVEFORM DISPLAYED WIDE QRS COMPLEXES (PVC'S) AND THE PATIENT, SUBSEQUENTLY, EXPIRED. THE CUSTOMER INQUIRED WHY THE SYSTEM DID NOT RESPOND TO THE CHANGE IN THE QRS COMPLEX. THIS REPORT OCCURRED OUTSIDE OF THE U.S., HOWEVER THE TM80 TELEPACK IS MARKETED IN THE U.S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616904 | BENEVISION TM80 TELEMETRY MONITOR | BENEVISION TM80 TELEMETRY MONITOR | MSX | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BENEVISION TM80 TELEMETRY MONITOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |