MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-08 for AXOXIMETER 4000 AVOX4000 AVOX 4000 manufactured by Accriva Diagnostics.
[97729232]
This mdr references accriva diagnostics' complaint number (b)(4) for avoximeter 4000 co-oximeter serial number (b)(4). A child case capturing the cuvette and lot number of the disposable device tested with this instrument is 7053171-31711 and is referenced by accriva diagnostics' complaint number (b)(4). Actual device not evaluated. Process evaluation was performed. Dhr reviewed showed no ncrs, capas, instrument repairs or other anomalies related to this complaint. Results: no results available since no evaluation performed. Conclusion: device not returned. Accriva has requested all data required for form fda 3500a.
Patient Sequence No: 1, Text Type: N, H10
[97729233]
Healthcare professional reported an unexpectedly high %cohb result with an avoximeter 4000 co-oximeter in a continuously ventilated nursing home patient. Blood gases and co-oximetry tests were being conducted every 12 hours. Test results were as expected except for one unexpectedly high %cohb result (5. 2%) that was clinically significant and above the patient's 48-hour baseline %cohb of 2. 1%. The patient received an unspecified treatment and subsequent blood gases and co-oximeter results returned to baseline. An internal investigation did not find any evidence that the patient was exposed to carbon monoxide. No medical complications or other events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00004 |
| MDR Report Key | 7173967 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-08 |
| Date of Report | 2018-04-13 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-03-11 |
| Device Manufacturer Date | 2016-05-05 |
| Date Added to Maude | 2018-01-08 |
| 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 | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXOXIMETER 4000 |
| Generic Name | SPECTRAL ABSORB. CURVE, OXYHEMOGLOBIN, CARBOXYHEMOGLOBIN, CARBON MONOXIDE |
| Product Code | JKS |
| Date Received | 2018-01-08 |
| Model Number | AVOX4000 |
| Catalog Number | AVOX 4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-08 |