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 2005-09-15 for ABL 700 SERIES * manufactured by Radiometer Medical Aps.
[408506]
Scalp ph of blood of fetuses can be used to decide if a cesarean section is indicated. When attempting to make blood scalp measurements for determining ph on fetuses while mother is in labor, up to 50% of samples are aborted because the blood sample is either contaminated with vaseline or silicone or because the blood sample is partly coagulated. When the measurement aborts the next sample cannot be taken immediately because of the low amount of blood available. This may cause a decision on a cesarean section to be delayed or possibly taken without the knowledge of scalp ph.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00017 |
| MDR Report Key | 654997 |
| Report Source | 01,05,06 |
| Date Received | 2005-09-15 |
| Date of Report | 2004-12-10 |
| Date Mfgr Received | 2003-06-23 |
| Date Added to Maude | 2005-12-22 |
| 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 | LEIF GUDNITZ, QUALITY CONSULTA |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 700 SERIES |
| Generic Name | BLOOD GAS ANALYZER WITH ADD. PARAMETERS |
| Product Code | CCE |
| Date Received | 2005-09-15 |
| Model Number | ABL 700 |
| Catalog Number | * |
| 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 | 644480 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | ABL 700 SERIES |
| Baseline Generic Name | BLOOD GAS ANALYZER WITH ADD. PARAMETERS |
| Baseline Model No | ABL 700 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-15 |