FDA Adverse Event
Malfunction
Summary report: N
LP6 VOLUME VENTILATOR
MDR report key: 54888
·
Received September 2, 1996
Report
- Report Number
- 2183157-1996-00025
- Event Type
- Malfunction
- Date Received
- September 2, 1996
- Date of Event
- August 14, 1996
- Report Date
- August 14, 1996
- Manufacturer
- AEQUITRON MEDICAL, 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 SERVICE OF PRODUCT, A MOTOR STALL, WITH AUDIBLE LOW PRESSURE ALARM, WAS FOUND DUE TO TRANSISTORS Q2 AND Q6 OR THE MOTOR BOARD BEING OUT OF SEPC. DEVICE RETURNED UNREPAIRED AT CUSTOMER'S REQUEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LP6 VOLUME VENTILATOR | VOLUME VENTILATOR | CBK | AEQUITRON MEDICAL, INC. | LP6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |