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.
[633244]
Two capillary samples were taken on a neonate. The first sample was analyzed on an abl735 blood gas analyzer indicating hb 6. 3 mmol/l. According to the qc logs, the device has performed according to specifications. As the medical staff considered the value too low according to the pt's condition, a new measurement was conducted. The reference measurement analyzed on an other blood gas analyzer confirmed that the value was higher. The second of the originally taken samples confirmed the higher value as 9. 4 mmol/l.
Patient Sequence No: 1, Text Type: D, B5
[7965781]
Still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2006-00039 |
| MDR Report Key | 871033 |
| Report Source | 01,05,06 |
| Date Received | 2006-09-15 |
| Date of Event | 2006-08-16 |
| Date Mfgr Received | 2006-08-16 |
| Date Added to Maude | 2007-06-27 |
| 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 | 851722 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-15 |