MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-24 for ABL800 SERIES ABL825 393-825 manufactured by Radiometer Medical Aps.
[662364]
When measuring po2 on the blood gas analyzer with flexq, a physician considered that the obtained po2 values to be abnormally high. This was confirmed by new measurements. No alarm was issued. The values were close to the values of atmospheric air were obtained. There has been no information of serious injury in the reported information.
Patient Sequence No: 1, Text Type: D, B5
[7875040]
The abnormally high po2 values are close to the values of atmospheric air which suggests, that air-bubbles has been introduced into the samples, and that the measurements may have been conducted on the secluded air.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2007-00007 |
| MDR Report Key | 859481 |
| Report Source | 05,06 |
| Date Received | 2007-05-24 |
| Date of Report | 2007-05-24 |
| Date of Event | 2007-04-23 |
| Date Mfgr Received | 2007-04-24 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-07-12 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL800 SERIES |
| Generic Name | ABL800FLEX |
| Product Code | CCE |
| Date Received | 2007-05-24 |
| Model Number | ABL825 |
| Catalog Number | 393-825 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855719 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | BROENSHOEJ(COPENHAGEN DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-24 |