ABL700 ABL725 392-725

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-05-26 for ABL700 ABL725 392-725 manufactured by Radiometer Medical Aps.

Event Text Entries

[459105] A too low ph-value was measured. No alarm was issued. The low-ph value may have been caused by a clot in the ph-chamber that was afterwards found at maintenance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002807968-2006-00029
MDR Report Key721384
Report Source01
Date Received2006-05-26
Date of Event2006-04-28
Date Mfgr Received2006-04-28
Date Added to Maude2006-06-05
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 FDA3
Event Location0
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABL700
Generic NameBLOOD GAS ANALYZER
Product CodeCCE
Date Received2006-05-26
Model NumberABL725
Catalog Number392-725
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key710452
ManufacturerRADIOMETER MEDICAL APS
Manufacturer AddressAKANDEVEJ 21 BRONSHOJ DA DK-2700
Baseline Brand NameABL725
Baseline Generic NameIN VITRO DIAGNOSTIC DEVICE, BLOOD GAS ANALYZER
Baseline Model NoABL725
Baseline Catalog NoUNK
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2006-05-26

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