FDA Adverse Event
Death
Summary report: N
EVITA
MDR report key: 412616
·
Received August 22, 2002
Report
- Report Number
- 2517967-2002-00064
- Event Type
- Death
- Date Received
- August 22, 2002
- Date of Event
- July 23, 2002
- Report Date
- August 22, 2002
- Manufacturer
- DRAEGER MEDICAL, INC.
- Product Code
- CBK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT: THE FACILITY EXPERIENCED AN ELECTRICAL STORM, WHICH CAUSED A MOMENTARY LOSS OF ELECTRICAL POWER AT THE FACILITY. THE CIRCUIT BREAKERS ON THE AIR COMPRESSORS AT THE FACILITY OPENED, WHICH LED TO THE LOSS OF AIR PIPELINE SUPPLY. A PT WAS BEING VENTILATED AT THE TIME OF THE POWER LOSS. THE PT WAS IN ICU AND WAS BEING MONITORED BY A HEART MONITOR, WENT ASYSTOLE, AND WAS THEN BAGGED BY HOSP PERSONNEL. AN HOUR AFTER THE POWER LOSS THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVITA | CONTINUOUS VENTILATOR | CBK | DRAEGER MEDICAL, INC. | 2 DURA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death |