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 |