MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-05-05 for AVOXIMETER 4000 W/110V AC ADAPTER AVOX4000-110 manufactured by International Technidyne Corp..
[5887399]
Healthcare professional reported inconsistent carboxyhemoglobin results from an avoximeter 4000 system. Co-oxymetry testing was performed on a patient of unk gender, age, weight, height or diagnosis. The test was repeated multiple times because the initial value was not consistent with expectations, and repeat results were inconsistent with subsequent testing. System operation and sample handling appeared appropriate based on the avoximeter user manual. Liquid and optical quality control tests passed successfully. The accuracy guidelines for carboxyhemoglobin results recommended by clia is <=3. 0%. The absolute difference between results (lowest value compared to the highest value) was 3. 4%, thus exceeding the limit of accuracy. The instrument was returned to itc for evaluation. Patient death did not occur and there were no serious injuries or other complications related to this event.
Patient Sequence No: 1, Text Type: D, B5
[13379015]
(b)(4). Method: the actual device was evaluated. Process evaluation was performed. No reports of non-conformance or other anomalies related to the complaint were identified. Results: maintenance problem. Precision of the device was found to be outside acceptable limits. Instrument repair and recalibration is required. Conclusion: out of calibration. The instrument failed wet qc testing and will be sent for repair. When it is returns from repair, it will undergo repeat qc testing to determine if instrument re-calibrated is required to meet precision specifications.
Patient Sequence No: 1, Text Type: N, H10
[62942579]
This follow-up mdr summarizes the results of (b)(4) which reports results of the second device evaluation. This mdr references itc complaint number (b)(4). Method: the actual device was evaluated. Instrument was serviced and was returned to itc for re-evaluation. Results: mechanical problem. Device failed wet quality control testing. Instrument repair and recalibration required. Conclusion: out of calibration.
Patient Sequence No: 1, Text Type: N, H10
[62942580]
Follow-up #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-2015-00029 |
| MDR Report Key | 4756846 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-05-05 |
| Date of Report | 2015-04-06 |
| Date of Event | 2015-04-06 |
| Date Mfgr Received | 2015-07-29 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2015-06-12 |
| 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 | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVOXIMETER 4000 W/110V AC ADAPTER |
| Generic Name | CARBON MONOXIDE TEST SYSTEM |
| Product Code | JKS |
| Date Received | 2015-05-05 |
| Returned To Mfg | 2015-04-23 |
| Model Number | AVOX4000-110 |
| Catalog Number | AVOX4000-110 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |