MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-09 for CMS GAS STATION * 316-201 manufactured by Scott Medical Products Div. Of Scott Specialty Gases.
[133798]
Blood gas analyzer malfunction. Machine would not calibrate. The svc rep for the co determined that the 12% 02 calibration gas was bad. Pt was transferred to another healthcare facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013477 |
| MDR Report Key | 161846 |
| Date Received | 1998-04-09 |
| Date of Report | 1998-03-23 |
| Date of Event | 1998-03-15 |
| Date Added to Maude | 1998-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMS GAS STATION |
| Generic Name | CALIBRATION GAS CYLINDER |
| Product Code | BXK |
| Date Received | 1998-04-09 |
| Model Number | * |
| Catalog Number | 316-201 |
| Lot Number | 093476 |
| ID Number | * |
| Device Expiration Date | 1999-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157588 |
| Manufacturer | SCOTT MEDICAL PRODUCTS DIV. OF SCOTT SPECIALTY GASES |
| Manufacturer Address | RT. 611 PLUMSTEADVILLE PA 18949 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-09 |