FDA Adverse Event
Malfunction
Summary report: N
LP10 VOLUME VENTILATOR
MDR report key: 221423
·
Received April 27, 1999
Report
- Report Number
- 2183157-1999-00097
- Event Type
- Malfunction
- Date Received
- April 27, 1999
- Date of Event
- April 6, 1999
- Report Date
- April 27, 1999
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED A CALL FROM IN HOME MEDICAL ON 04/06/1999. CALLED TO REPORT THE FOLLOWING PROBLEM: WILL NOT LOW PRESSURE ALARM WITH CIRCUIT REMOVED. FOUND DURING INITIAL CHECKOUT. NOT ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LP10 VOLUME VENTILATOR | VOLUME VENTILATOR | CBK | NELLCOR PURITAN BENNETT | LP20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |