FDA Adverse Event
Malfunction
Summary report: N
FILTERLINE SET
MDR report key: 1690900
·
Received May 11, 2010
Report
- Report Number
- 8044004-2010-00001
- Event Type
- Malfunction
- Date Received
- May 11, 2010
- Date of Event
- April 18, 2010
- Report Date
- May 10, 2010
- Manufacturer
- ORIDION MEDICAL 1987 LTD.
- Product Code
- CCK
- PMA / PMN Number
- 980324
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY HAS ADDRESSED THE PRODUCTION ISSUE AND PLANS TO CONDUCT A FIELD ACTION TO REMOVE PRODUCT FROM THE FIELD AND REPLACE WITH NEW.
Description of Event or Problem · 1
DURING INTUBATION OF A CARDIAC ARREST PT IN AN AMBULANCE, TEAM CONNECTED A FILTERLINE TO A LIFEPAK 12 DEFIBRILLATOR AND DID NOT GET CO2 READINGS ALTHOUGH IT WAS CLEAR THAT PT WAS BREATHING. TEAM THEN USED A BACKUP CO2 MONITOR TO MONITOR CO2. PT'S PULSE RETURNED BUT PATIENT EVENTUALLY DIED. TEAM STATE CLEARLY THAT OUTCOME WAS NOT AS A RESULT OF THE DEVICE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILTERLINE SET | CO2 SAMPLING LINE | CCK | ORIDION MEDICAL 1987 LTD. | Q0905123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |