FDA Adverse Event
Malfunction
Summary report: N
ACHIEVA VOLUME VENTILATOR
MDR report key: 267108
·
Received February 29, 2000
Report
- Report Number
- 2183157-2000-00056
- Event Type
- Malfunction
- Date Received
- February 29, 2000
- Date of Event
- February 4, 2000
- Report Date
- February 29, 2000
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED A CALL FROM REPRESENTATIVE OF AN AGENCY ON 02/04/2000. AGENCY CALLED TO REPORT THE FOLLOWING PROBLEM: AUDIBLE ALARM SHUTS OFF AFTER APPROX 1 MINUTE OF ACTIVATION. SALES REP UNABLE TO VERIFY THE ALLEGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACHIEVA VOLUME VENTILATOR | VOLUME VENTILATOR | CBK | NELLCOR PURITAN BENNETT | ACHIEVA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |