FDA Adverse Event
Injury
Summary report: N
MPV, 7200SPE, W/PSV
MDR report key: 1119024
·
Received August 15, 2008
Report
- Report Number
- 2024500-2008-00037
- Event Type
- Injury
- Date Received
- August 15, 2008
- Report Date
- July 16, 2008
- Manufacturer
- CARLSBAD-RX
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS BEEN CONTACTED TO OBTAIN FURTHER INFORMATION AND AT THIS TIME NO NEW INFORMATION HAS BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION IS RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE EXHALATION VALVE AND THE SECURITY VALVE DID NOT OPEN AND THAT 'BAROTRAUMA' OCCURRED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MPV, 7200SPE, W/PSV | NONE | CBK | CARLSBAD-RX | 7200SPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |