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 2006-09-15 for ABL700 SERIES ABL735 393-735 manufactured by Radiometer Medical Aps.
[640793]
An arterial blood sample was drawn from an adult pt using a 195 mikrol syringe. When analyzed on two different abl 735 blood gas analyzers, the sample resulted in the two different values cthb = 7. 9 mmol/l and cthb = 5. 4 mmol/l. There is no allegation of death or serious injury in the reported info.
Patient Sequence No: 1, Text Type: D, B5
[7909854]
Still under investigation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3002807968-2006-00040 |
MDR Report Key | 875689 |
Report Source | 01,05,06 |
Date Received | 2006-09-15 |
Date of Event | 2006-08-18 |
Date Mfgr Received | 2006-08-18 |
Date Added to Maude | 2007-07-09 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
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 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ABL700 SERIES |
Generic Name | ABL700 |
Product Code | CCE |
Date Received | 2006-09-15 |
Model Number | ABL735 |
Catalog Number | 393-735 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | NA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 855282 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2006-09-15 |