FDA Adverse Event
Malfunction
Summary report: N
LIFE PULSE HIGH FREQUENCY VENTILATOR
MDR report key: 225136
·
Received May 21, 1999
Report
- Report Number
- 1719232-1999-00004
- Event Type
- Malfunction
- Date Received
- May 21, 1999
- Date of Event
- April 27, 1999
- Report Date
- May 21, 1999
- Manufacturer
- BUNNELL, INC.
- Product Code
- LSZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER REPORTED DEVICE ALARM (VENT FAULT 05) CONDITION WHICH PROMPTS USER TO RESET DEVICE. USER REPORTED THAT DEVICE COULD NOT BE RESET WITHOUT RECURRENCE OF THE ALARM CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFE PULSE HIGH FREQUENCY VENTILATOR | VENTILATOR | LSZ | BUNNELL, INC. | 203 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DAY |