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 |