FDA Adverse Event
Malfunction
Summary report: N
PULMONETIC
MDR report key: 726021
·
Received June 6, 2006
Report
- Report Number
- 2031702-2006-00138
- Event Type
- Malfunction
- Date Received
- June 6, 2006
- Report Date
- June 6, 2006
- Manufacturer
- PULMONETIC SYSTEMS, INC.
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN UNIT IS INSTALLED ON FLOOR STAND AND THE LOWER LEFT FRONT OF THE UNIT IS PRESSED UPON, THE UNIT SHUTS DOWN. SERVICE COMPANY PERFORMED BASIC CHECK AND CONFIRMED THE VENT DOES NOT SHUT DOWN, BUT THE TURBINE DOES STOP AND GIVES DISC/SENSE ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONETIC | VOLUME VENTILATOR | CBK | PULMONETIC SYSTEMS, INC. | LTV 950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |