ABL700 SERIES 393-725

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3002807968-2007-00008
MDR Report Key859478
Report Source05
Date Received2007-05-31
Date of Report2007-05-31
Date of Event2007-04-30
Date Mfgr Received2007-05-01
Date Added to Maude2007-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer StreetAKANDEVEJ 21
Manufacturer CityBRONSHOJ DK-2700
Manufacturer CountryDA
Manufacturer PostalDK-2700
Manufacturer Phone8273827
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABL700 SERIES
Generic NameALB725
Product CodeCCE
Date Received2007-05-31
Catalog Number393-725
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key855722
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAKANDEVEJ 21 BRONSHOJ DA DK-2700


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-05-31

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