FDA Adverse Event
Other
Summary report: N
CAREVENT AUTOMATIC TRANSPORT VENTILATOR
MDR report key: 437300
·
Received January 7, 2003
Report
- Report Number
- 9610861-2002-00001
- Event Type
- Other
- Date Received
- January 7, 2003
- Date of Event
- November 21, 2002
- Report Date
- December 9, 2002
- Manufacturer
- O-TWO SYSTEMS INTL., INC.
- Product Code
- CBK
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HAD NO OXYGEN DELIVERY PRESSURE DURING THE VENTILATION OF A PATIENT PRIOR TO A CT SCAN PROCEDURE. THE LOW INPUT PRESSURE AND BSI ALARM CAME ON. TWO PARAMEDICS AND A RESPIRATORY THERAPIST WERE PRESENT. THE ATV+ VENTILATOR WAS EXCHANGED WITH A SECOND VENTILATOR TO RESUME VENTILATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREVENT AUTOMATIC TRANSPORT VENTILATOR | AUTOMATIC TRANSPORT VENTILATOR MEDICAL DEVICE | CBK | O-TWO SYSTEMS INTL., INC. | 01CV6000 | 01-1753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |