FDA Adverse Event
Malfunction
Summary report: N
LIFE PULSE HIGH FREQUENCY VENTILATOR
MDR report key: 299654
·
Received October 4, 2000
Report
- Report Number
- 1719232-2000-00007
- Event Type
- Malfunction
- Date Received
- October 4, 2000
- Date of Event
- September 7, 2000
- Report Date
- October 2, 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
INACCURATE MONITORING BY THE LIFE PULSE HIGH FREQUENCY VENTILATOR WHILE ON A PT. NO HARM OR INJURY TO THE PT. NOTE: INACCURATE MONITORING IS NOT NORMALLY AN MDR EVENT. IN THIS CASE THERE WERE TWO PT BOXES WHICH CONTRIBUTED TO THIS EVENT.
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 |