FDA Adverse Event
Death
Summary report: N
E-CAIOV S/5 COMPACT AIRWAY MODULE
MDR report key: 3687387
·
Received March 11, 2014
Report
- Report Number
- 9610105-2014-00002
- Event Type
- Death
- Date Received
- March 11, 2014
- Date of Event
- January 31, 2014
- Report Date
- February 4, 2014
- Manufacturer
- GE HEALTHCARE FINLAND OY
- Product Code
- CCL
- PMA / PMN Number
- K051092
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PT WEIGHT: PT WEIGHT WAS NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THIS RECORD REPORTS A GE HEALTHCARE MODULE WAS BEING USED DURING A DENTAL PROCEDURE IN WHICH THE PT CODED AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN REPORTS THERE IS A DIFFERENCE IN THE PERCENTAGE OF ANESTHESIA AGENT HE DIALS IN AND THE PERCENTAGE COMPUTED BY THE MODULE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145759 | E-CAIOV S/5 COMPACT AIRWAY MODULE | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE | CCL | GE HEALTHCARE FINLAND OY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Death |