FDA Adverse Event
Malfunction
Summary report: N
LP10 VOLUME VENTILATOR
MDR report key: 183752
·
Received August 19, 1998
Report
- Report Number
- 2183157-1998-00131
- Event Type
- Malfunction
- Date Received
- August 19, 1998
- Date of Event
- July 20, 1998
- Report Date
- August 19, 1998
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT REC'D A CALL ON 07/20/1998. CALLED TO REPORT THE FOLLOWING PROBLEM: WHEN UNIT IS TURNED ON IN THE BACK ALL LEDS COME ON AND A CONSTANT SOLID AUDIBLE ALARM SOUNDS. THIS HAPPENS IN STAND-BY MODE AS WELL AS IN OPERATING MODES. THE "LED"S AS WELL AS AUDIBLE ALARMS DO NOT RESET AND THE UNIT WILL NOT CYCLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LP10 VOLUME VENTILATOR | VOLUME VENTILATOR | CBK | NELLCOR PURITAN BENNETT | LP10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |