FDA Adverse Event
Malfunction
Summary report: N
PULMONETIC
MDR report key: 682043
·
Received February 28, 2006
Report
- Report Number
- 2031702-2006-00059
- Event Type
- Malfunction
- Date Received
- February 28, 2006
- Date of Event
- January 31, 2006
- Report Date
- February 27, 2006
- Manufacturer
- PULMONETIC SYSTEMS, INC.
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING SVC THE UNIT WOULD NOT POWER UP ON ANY POWER SOURCE. THE C21 CAPACITOR ON THE MOTOR BOARD FAILED EFFECTIVELY SHORTING THE +15V LINE TO GND. THE MOTOR BOARD DUE TO C21 CAPACITOR TO CORRECT THE PROBLEM.
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 | UNKNOWN | Other |