MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-04-10 for ABL700SERIES AND ABL800SERIES ABL825 * manufactured by Radiometer Medical Aps.
[450865]
It is possible for the abl 700 analyzer to make a calculation of the cto2 (a-v) value if the po2 value and the so2 is keyed in manually. The calculation is used for evaluating the oxygen consumption of the tissue cells. In the operators manual for abl 700 page 6-24 there is an explanation for this calculation. But the so2 value is not mentioned in the manual, by mistake. In the reference manual the formula is correct. The customer has noticed that the analyzer does not use the same formula for the calculation as mentioned in the manual. If the vlaue for so2 is not keyed in, the analyzer will estimate a value for so2 in relation to the po2 value keyed in. It is not possible to calculate the quantity of the error because of the missing so2 value. But is is possible that a patient migh get maltreated. The formula for this calculation, will be corrected by the next update of the manual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00022 |
| MDR Report Key | 699813 |
| Report Source | 01 |
| Date Received | 2006-04-10 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-02-24 |
| Date Mfgr Received | 2006-02-24 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-04-17 |
| 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 |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL700SERIES AND ABL800SERIES |
| Generic Name | BLOOD GAZ ANALYZER |
| Product Code | CCE |
| Date Received | 2006-04-10 |
| Model Number | ABL825 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688903 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| 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 | 1. Other | 2006-04-10 |