FDA Adverse Event
Other
Summary report: N
ESPRIT
MDR report key: 592373
·
Received April 8, 2005
Report
- Report Number
- 592373
- Event Type
- Other
- Date Received
- April 8, 2005
- Date of Event
- April 2, 2005
- Report Date
- April 8, 2005
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
A CRITICAL HEART PATIENT WAS BEING TRANSPORTED FROM THE INTENSIVE CARE UNIT TO THE CARDIAC CATHETERIZATION LAB WHEN THE VENTILATOR BEGAN TO FLASH AN OXYGEN ALARM. IT HAD BEEN SET TO 100% AND ALSO THE PATIENT'S SPO2 WAS DECREASING FROM BASELINE. THE MANUFACTURER'S TECHNICAL REPRESENTATIVE DID A COMPLETE OPERATIONAL CHECK ON THE UNIT AND ALL FUNCTIONS OPERATED NORMALLY. IT WAS SUGGESTED THAT PERHAPS THE EXTERNAL OXYGEN SENSOR HAD BEEN CONNECTED INTO THE BREATHING CIRCUIT AT THE INCORRECT LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT | VENTILATOR | CBK | RESPIRONICS CALIFORNIA, INC. | ESPRIT | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |