MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-03-30 for RAPIDPOINT 400 109824 manufactured by Chiron Diagnostics Corp..
[165530]
A step increase in the signal output of the partial oxygen pressure sensor for the rapidpoint 400 sensor may occur. Depending on the slope determined at schedule (every 30 minutes) calibration, the absolute partial pressure of oxygen value could be reported highter than the actual pt value. The rapidpoint 400 software is designed to determine the difference in output between washes before or after consecutive pt samples and flag any analytical partial pressure of oxygen results which manifests in a signal of 0. 5na(nanoampere) or greater. However, signal differences below 0. 5na are not flagged. No serious injuries or death is associated with this event. Initial report of this event was as a result of evaluation of internal testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-1999-00002 |
| MDR Report Key | 217078 |
| Report Source | 00 |
| Date Received | 1999-03-30 |
| Date of Report | 1999-03-18 |
| Date of Event | 1999-03-18 |
| Date Mfgr Received | 1999-03-18 |
| Date Added to Maude | 1999-04-06 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDPOINT 400 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CCC |
| Date Received | 1999-03-30 |
| Model Number | NA |
| Catalog Number | 109824 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 210562 |
| Manufacturer | CHIRON DIAGNOSTICS CORP. |
| Manufacturer Address | 63 NORTH ST. MEDFIELD MA 020521688 US |
| Baseline Brand Name | RAPIDPOINT 400 |
| Baseline Generic Name | BLOOD GAS ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 109824 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-30 |