FDA Adverse Event
Death
Summary report: N
ATLAS MONITOR
MDR report key: 1944015
·
Received December 21, 2010
Report
- Report Number
- 3023750-2010-00169
- Event Type
- Death
- Date Received
- December 21, 2010
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DQA
- PMA / PMN Number
- K022084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT PRESENTED AT (B)(6) WITH CHEST PAINS AND DROVE TO (B)(6). PRESENTED AT LOCAL (B)(6) SURGERY FOR EVAL AND WAS ADMITTED TO HOSP FOR OVERNIGHT EVAL. PT ADMITTED TO WARD 1 BED AND ATTACHED TO WELCH ALLYN 62000 (ATLAS) MONITOR, (B)(4) FOR OBSERVATION. AT 0450, THE PT WAS CHECKED AND FOUND TO BE DECEASED. CAUSE OF DEATH: CARDIAC ARREST MYOCARDIAL INFARCTION. AUDIBLE ALARMS WERE VERY LOW AND NOT HEARD BY STAFF, NOR WAS THERE ANY PRINTOUT REPORT OF PT ALARMS OR EVENTS ON THE MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS MONITOR | DQA | WELCH ALLYN PROTOCOL, INC. | 622NP-E1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |