FDA Adverse Event
Malfunction
Summary report: N
LP10 VOLUME VENTILATOR
MDR report key: 47946
·
Received September 20, 1996
Report
- Report Number
- 2183157-1996-00034
- Event Type
- Malfunction
- Date Received
- September 20, 1996
- Report Date
- August 22, 1996
- Manufacturer
- AEQUITRON MEDICAL, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING SERVICE OF PRODUCT A MODE SWITCH ERROR WAS FOUND WITH LED ON, NO AUDIBLE ALARM SOUNDING, DUE TO FUSE F2 ON THE MOTOR BOARD BEING OUT OF SPECIFICATION. REPLACED F2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LP10 VOLUME VENTILATOR | VENTILATOR | CBK | AEQUITRON MEDICAL, INC. | LP10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |