MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-06-19 for ABL800 SERIES ABL825 * manufactured by Radiometer Medical Aps.
[462289]
After treatment of four patients based on measurements from the bloodgas analyser abl825, it was observed that all the four measurement results used for the treatment, were identical with the measurement conducted just before the measurements of the four patients. No harm to the patients has been reported. The problem is caused by a sw bug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00030 |
| MDR Report Key | 730804 |
| Report Source | 01 |
| Date Received | 2006-06-19 |
| Date of Report | 2006-06-16 |
| Date of Event | 2006-05-16 |
| Date Mfgr Received | 2006-05-17 |
| Date Added to Maude | 2006-07-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GERT NIELSEN |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273057 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL800 SERIES |
| Generic Name | * |
| Product Code | CCE |
| Date Received | 2006-06-19 |
| Model Number | ABL825 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 719092 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| Baseline Brand Name | ABL700SERIES AND ABL800SERIES |
| Baseline Generic Name | BLOOD GAZ ANALYZER |
| Baseline Model No | ABL825 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-19 |