FDA Adverse Event
Other
Summary report: N
BUNNELL
MDR report key: 168086
·
Received May 11, 1998
Report
- Report Number
- MW1013832
- Event Type
- Other
- Date Received
- May 11, 1998
- Date of Event
- January 16, 1997
- Report Date
- January 17, 1997
- Manufacturer
- BUNNELL, INC.
- Product Code
- LSZ
- Report Source
- Voluntary report
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
HIGH FREQUENCY JET VENTILATOR CEASED TO FUNCTION PROPERLY. PT WAS PLACED ON CONVENTIONAL MECHANICAL VENTILATOR WHILE MFR WAS CONTACTED FOR ASSISTANCE. MFR CONFIRMED JET VENTILATOR WAS PROBABLY FAULTY; ARRANGED REPLACEMENT AND ISSUED INSTRUCTIONS & AUTHORIZATION FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUNNELL | LIFE PULSE HIGH FREQUENCY JET VENTILATOR | LSZ | BUNNELL, INC. | CD-185-17 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DAY | Other |