FDA Adverse Event
Malfunction
Summary report: N
PULMONETIC
MDR report key: 481793
·
Received August 28, 2003
Report
- Report Number
- 2031702-2003-00248
- Event Type
- Malfunction
- Date Received
- August 28, 2003
- Report Date
- August 28, 2003
- Manufacturer
- PULMONETIC SYSTEMS, INC.
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE VENTILATOR IS NOT COMPLETING THE POWER ON SELF TEST. THE LEDS ILLUMINATE JUST FOR A FEW SECONDS THEN GO OUT AND IT TRIES TO BEGIN THE TEST AGAIN BUT IT'S THE SAME SITUATION. THE TURBINE IS NOT WORKING AND FOR TURNING IT OFF USER HAS TO DISCONNECT AND THE ALARM BEGINS TO SOUND AND DISPLAY VENT INOP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONETIC | VOLUME VENTILATOR | CBK | PULMONETIC SYSTEMS, INC. | LTV 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |