FDA Adverse Event
Malfunction
Summary report: N
PULMONETIC
MDR report key: 1030170
·
Received April 14, 2008
Report
- Report Number
- 2031702-2008-00068
- Event Type
- Malfunction
- Date Received
- April 14, 2008
- Report Date
- April 14, 2008
- Manufacturer
- CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K051767
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS - TESTING BY THE MANUFACTURER IS ONGOING.
Description of Event or Problem · 1
THE VENTILATOR ALLEGEDLY SHUT DOWN ON THE PT. THE PT WAS BAGGED UNTIL PLACED ON A BACKUP 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 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |