MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2005-11-30 for BLOODGAS ANALYZER ABL 725 * manufactured by Radiometer Medical Aps.
[425295]
An abl725 analyzer reported a 1 point calibration drift error on the pco2 electrode. Instead of following the procedure for this kind of problem in the operator's manual (error no. 376), the user then ran four calibrations in a row which all reported the same drift problem. Then a fifth calibration was run with no drift problem, the user trusted this results, but the result made no sense to the doctor. The analyzer was then examined and a clot was found in the first chamber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2005-00011 |
| MDR Report Key | 649504 |
| Report Source | 01,05,06 |
| Date Received | 2005-11-30 |
| Date of Report | 2005-11-28 |
| Date of Event | 2005-11-05 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-12-07 |
| 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 | LISE-LOTTE RINGBY, SPEC. |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | ** |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOODGAS ANALYZER |
| Generic Name | ABL 700 SERIES AND ABL 800 SERIES |
| Product Code | CCE |
| Date Received | 2005-11-30 |
| Model Number | ABL 725 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 638995 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * BRONSHOJ DA |
| Baseline Brand Name | BLOODGAS ANALYZER |
| Baseline Generic Name | ABL 700 SERIES AND ABL 800 SERIES |
| Baseline Model No | ABL 725 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-11-30 |
| 2 | 0 | 2005-11-30 |