FDA Adverse Event
Malfunction
Summary report: N
PULMONETIC
MDR report key: 1001845
·
Received February 25, 2008
Report
- Report Number
- 2031702-2008-00039
- Event Type
- Malfunction
- Date Received
- February 25, 2008
- Date of Event
- January 20, 2008
- Report Date
- February 25, 2008
- Manufacturer
- CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
- Product Code
- CBK
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE ON THE PT, THE VENTILATOR MADE A NOISE AND AIR STOPPED FLOWING, THE MOTHER OF THE PT SAYS THE ALARMS DID NOT GO OFF IMMEDIATELY UNTIL SHE TURNED THE POWER OFF. POWER LOST ALARM OCCURRED. PT WAS PLACED ON A BACK-UP VENTILATOR. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONETIC | VOLUME VENTILATOR | CBK | CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. | LTV 900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |