MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-07-17 for ABL700 ABL735 393-725 manufactured by Radiometer Medical Aps.
[490027]
A too low na-value was measured on an abl735 blood gas analyzer. No alarm was issued. The low na value may have been caused by a defective reference electrode. Allegedly 4 or 5 patients were inappropriately treated for too low na values in the bloodstream. No serious injury or death has been reported as a consequence of these treatments.
Patient Sequence No: 1, Text Type: D, B5
[7794184]
The hospital alleges the reference membrane is drifting after 4 or 5 days. Additional tests are undertaken.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3002807968-2006-00036 |
MDR Report Key | 743489 |
Report Source | 01 |
Date Received | 2006-07-17 |
Date of Report | 2006-07-14 |
Date of Event | 2006-06-16 |
Date Added to Maude | 2006-08-04 |
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 | PIERRE PELLETIER |
Manufacturer Street | AKANDEVEJ 21 |
Manufacturer City | BRONSHOJ DK-2700 |
Manufacturer Country | DA |
Manufacturer Postal | DK-2700 |
Manufacturer Phone | 8273614 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ABL700 |
Generic Name | BLOOD GAS ANALYZER |
Product Code | CCE |
Date Received | 2006-07-17 |
Model Number | ABL735 |
Catalog Number | 393-725 |
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 | 731285 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2006-07-17 |