MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-15 for AIRLIFE ADULT CO2 DETECTOR 2K8085 manufactured by Vyaire Medical.
[187435491]
The suspect device is not available for return, as it was discarded. No further evaluation can be completed at this time. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[187435492]
The customer reported that the airlife adult co2 detector failed to change color in the presence of exhaled co2 during code blue on an intubated patient. It was also reported that the tube was in the correct position. The customer confirmed that there was no patient harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-2020-00002 |
| MDR Report Key | 9593562 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | SEEBREATH AB |
| Manufacturer Street | BIRGER JARLSGATAN 2 STOCKHOLM STOCKHOLMS LAN [SE-01] |
| Manufacturer City | STOCKHOLM, 11434 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 11434 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE ADULT CO2 DETECTOR |
| Generic Name | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Product Code | CCK |
| Date Received | 2020-01-15 |
| Model Number | AIRLIFE ADULT CO2 DETECTOR |
| Catalog Number | 2K8085 |
| Lot Number | CC19-A10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |