FDA Adverse Event
Malfunction
Summary report: N
LIFE PULSE HIGH FREQUENCY VENTILATOR
MDR report key: 288593
·
Received July 29, 2000
Report
- Report Number
- 1719232-2000-00005
- Event Type
- Malfunction
- Date Received
- July 29, 2000
- Date of Event
- June 1, 2000
- Report Date
- July 27, 2000
- Manufacturer
- BUNNELL INC.
- Product Code
- LSZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
DEVICE RECEIVED FOR ROUTINE SERVICE FOUND TO HAVE A FAILED TRANSIENT VOLTAGE SUPPRESSOR. NOTE FOUND ON DEVICE ADVISING OF ALARM CONDITION. FAILURE INVESTIGATION IDENTIFIED THE FAILURE (DATE 07/20/2000).
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 | UNKNOWN |