MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-31 for ABL700 SERIES 393-725 manufactured by Radiometer Medical Aps.
[15606838]
Data from a blood sample analyzed on an blood gas analyzer was displayed correctly on the monitor and transferred correctly to radiance. However, the next 10 print-outs was all including the data of this sample. The repeated print-out of the same sample could have resulted in mix-up of patient data. The operator noticed the mistake and no patients were mistreated as a result. At present, the cause of the incident is not clear. Investigation is continues.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002807968-2007-00008 |
MDR Report Key | 859478 |
Report Source | 05 |
Date Received | 2007-05-31 |
Date of Report | 2007-05-31 |
Date of Event | 2007-04-30 |
Date Mfgr Received | 2007-05-01 |
Date Added to Maude | 2007-07-12 |
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 | 0 |
Event Location | 0 |
Manufacturer Street | AKANDEVEJ 21 |
Manufacturer City | BRONSHOJ DK-2700 |
Manufacturer Country | DA |
Manufacturer Postal | DK-2700 |
Manufacturer Phone | 8273827 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ABL700 SERIES |
Generic Name | ALB725 |
Product Code | CCE |
Date Received | 2007-05-31 |
Catalog Number | 393-725 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 855722 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2007-05-31 |