MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-10-27 for IL 482 CO-OXIMETER 0000482001 manufactured by Instrumentation Laboratory Co..
[236643]
According to the complaint text, an incident occurred with a customer's il 482 co-oximeter in their neonatal intensive care unit. Calibration was successfully performed on the instrument, as were three acceptable levels of controls; however, the methemoglobin results were questionable (met hgb result between 5-10 for neonates receiving nitric oxide therapy). The problem was later determined by service to be due to the hemolyzer. The part was replaced and results were checked and correlated to an alternate site. Based on these elevated methemoglobin values, patient's (neonates) were treated more aggressively before the problem was discovered. There is no indication from the complaint or a follow-up letter from the site that the neonates involved were adversely impacted by the more aggressive treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217183-2001-00003 |
| MDR Report Key | 359165 |
| Report Source | 05,06 |
| Date Received | 2001-10-27 |
| Date of Report | 2001-10-26 |
| Date Mfgr Received | 2001-09-27 |
| Device Manufacturer Date | 1995-02-01 |
| Date Added to Maude | 2001-11-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROL MARBLE, MANAGER |
| Manufacturer Street | 113 HARTWELL AVE |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal | 02421 |
| Manufacturer Phone | 7818614467 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IL 482 CO-OXIMETER |
| Generic Name | CO-OXIMETER |
| Product Code | JKS |
| Date Received | 2001-10-27 |
| Model Number | 482 |
| Catalog Number | 0000482001 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 348339 |
| Manufacturer | INSTRUMENTATION LABORATORY CO. |
| Manufacturer Address | 113 HARTWELL AVE. LEXINGTON MA 02421 US |
| Baseline Brand Name | IL 482 CO-OXIMETER |
| Baseline Generic Name | CO-OXIMETER |
| Baseline Model No | 482 |
| Baseline Catalog No | 0000482001 |
| Baseline Device Family | CRITICAL CARE PRODUCT LINE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862253 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-27 |