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 ABL 715 * manufactured by Radiometer Medical Aps.
[15442432]
Intermittent shift in calcium values led to shift of treatment. The dates of the event are unknown.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002807968-2004-00008 |
MDR Report Key | 636045 |
Report Source | 01,05,06 |
Date Received | 2005-09-15 |
Date of Report | 2004-12-10 |
Date Mfgr Received | 2002-12-16 |
Date Added to Maude | 2005-09-22 |
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 |
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 ADDITIONAL PARAMETER |
Product Code | CCE |
Date Received | 2005-09-15 |
Model Number | ABL 715 |
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 | 625587 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | * * * |
Baseline Brand Name | ABL 700 SERIES |
Baseline Generic Name | BLOOD GAS ANALYZER WITH ADDITIONAL PARAMETER |
Baseline Model No | ABL 715 |
Baseline Catalog No | * |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2005-09-15 |