ABL700 SERIES ABL735 393-735

MAUDE Adverse Event Report

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.

Event Text Entries

[640793] An arterial blood sample was drawn from an adult pt using a 195 mikrol syringe. When analyzed on two different abl 735 blood gas analyzers, the sample resulted in the two different values cthb = 7. 9 mmol/l and cthb = 5. 4 mmol/l. There is no allegation of death or serious injury in the reported info.
Patient Sequence No: 1, Text Type: D, B5


[7909854] Still under investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807968-2006-00040
MDR Report Key875689
Report Source01,05,06
Date Received2006-09-15
Date of Event2006-08-18
Date Mfgr Received2006-08-18
Date Added to Maude2007-07-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGERT NIELSEN
Manufacturer StreetAKANDEVEJ 21
Manufacturer CityBRONSHOJ DK-2700
Manufacturer CountryDA
Manufacturer PostalDK-2700
Manufacturer Phone8273057
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameABL700 SERIES
Generic NameABL700
Product CodeCCE
Date Received2006-09-15
Model NumberABL735
Catalog Number393-735
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key855282
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAKANDEVEJ 21 BRONSHOJ DA DK-2700


Patients

Patient NumberTreatmentOutcomeDate
10 2006-09-15

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