FDA Adverse Event
Injury
Summary report: N
ALARIS SYSTEM ETCO2 MONITOR
MDR report key: 1231595
·
Received November 13, 2008
Report
- Report Number
- 2016493-2008-00165
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 14, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- CCK
- PMA / PMN Number
- K031741
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.
Description of Event or Problem · 1
BIOMED REPORTED PT WAS RECEIVING PCA MORPHINE AND BECAME UNRESPONSIVE. TWO STAFF MEMBERS THINK ETCO2 DID NOT ALARM. MORPHINE WAS DISCONTINUED, PT WAS STIMULATED; ABGS, BLOOD CULTURES AND CHEST X-RAY WERE DONE. PT PLACED ON BIPAP, GIVEN NARCAN BOLUS, AND NARCAN DRIP WAS INITATED. PT IS NOW FINE WITH NO LASTING EFFECTS. EVENT LOGS RECEIVED AND INVESTIGATION IS ONGOING. FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SYSTEM ETCO2 MONITOR | CCK, ETCO2 MONITOR | CCK | CARDINAL HEALTH ALARIS PRODUCTS | 8300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | PCU| PCA 12532789 |