MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-05-26 for ABL700 ABL725 392-725 manufactured by Radiometer Medical Aps.
[459105]
A too low ph-value was measured. No alarm was issued. The low-ph value may have been caused by a clot in the ph-chamber that was afterwards found at maintenance.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002807968-2006-00029 |
MDR Report Key | 721384 |
Report Source | 01 |
Date Received | 2006-05-26 |
Date of Event | 2006-04-28 |
Date Mfgr Received | 2006-04-28 |
Date Added to Maude | 2006-06-05 |
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 | ABL700 |
Generic Name | BLOOD GAS ANALYZER |
Product Code | CCE |
Date Received | 2006-05-26 |
Model Number | ABL725 |
Catalog Number | 392-725 |
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 | 710452 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
Baseline Brand Name | ABL725 |
Baseline Generic Name | IN VITRO DIAGNOSTIC DEVICE, BLOOD GAS ANALYZER |
Baseline Model No | ABL725 |
Baseline Catalog No | UNK |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2006-05-26 |