FDA Adverse Event
Malfunction
Summary report: N
LP10 VOLUME VENTILATOR
MDR report key: 249447
·
Received November 4, 1999
Report
- Report Number
- 2183157-1999-00255
- Event Type
- Malfunction
- Date Received
- November 4, 1999
- Date of Event
- October 5, 1999
- Report Date
- November 4, 1999
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REPRESENTATIVE ON 10/05/1999, WHO CALLED TO REPORT THE FOLLOWING PROBLEM: ALL LEDS ON, CONSTANT SINGLE TONE ALARM. NO # VOLUME DELIVERED. NO PT HARM.
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 |