MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-07-23 for SYNTHESIS 1725 1725097 manufactured by Instrumentation Laboratory Co..
[15674777]
A customer reported that an adult male patient was hospitalized for suspected co poisoning with a cohb. Reading of 22. 8% on their il synthesis model 1725. After several days the level did not drop significantly and the patient was given increasing levels of oxygen through a low flow mask device. Records show the patient was given 100% oxygen for approximately 12 hrs before the technician noted that the synthesis was malfunctioning due to a clot in the optical window. After removal of the clot, the patient was re-tested on the synthesis and the cohb reading was zero. According to the hospital, the patient was released with no adverse affects from the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020992-1999-00001 |
| MDR Report Key | 233575 |
| Report Source | 05 |
| Date Received | 1999-07-23 |
| Date of Report | 1999-07-23 |
| Date of Event | 1999-06-26 |
| Date Mfgr Received | 1999-06-26 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1999-07-30 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNTHESIS |
| Generic Name | BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER |
| Product Code | JKS |
| Date Received | 1999-07-23 |
| Returned To Mfg | 1999-07-16 |
| Model Number | 1725 |
| Catalog Number | 1725097 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 226404 |
| Manufacturer | INSTRUMENTATION LABORATORY CO. |
| Manufacturer Address | VIALE DELL'INDUSTRIA 3 PADERNO DUGNANO IT 20037 |
| Baseline Brand Name | SYNTHESIS |
| Baseline Generic Name | BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER |
| Baseline Model No | 1725 |
| Baseline Catalog No | 1725097 |
| Baseline ID | 97080410 |
| Baseline Device Family | 1700 SERIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K963800 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-07-23 |