COMPACT ABSORBER *

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 2006-09-07 for COMPACT ABSORBER * manufactured by Ge Healthcare Finland Oy.

Event Text Entries

[22048087] Ge healthcare plans to undertake a field correction to address this condition.
Patient Sequence No: 1, Text Type: N, H10


[22179256] Customer reportedly noted high airway pressure. There was no reported patient injury. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610105-2006-00021
MDR Report Key878941
Report Source05
Date Received2006-09-07
Date of Report2006-09-07
Date of Event2006-07-17
Date Mfgr Received2006-07-17
Device Manufacturer Date2006-07-01
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 FDA3
Event Location0
Manufacturer ContactANN LEBAR
Manufacturer Street9900 INNOVATION DRIVE MAIL STOP RP2138
Manufacturer CityWAUWATOSA WI 53226
Manufacturer CountryUS
Manufacturer Postal53226
Manufacturer Phone4147213947
Manufacturer G1GE HEALTHCARE FINLAND OY
Manufacturer Street*
Manufacturer City*
Manufacturer CountryFI
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPACT ABSORBER
Generic NameCARBON DIOXIDE ABSORBER
Product CodeBSF
Date Received2006-09-07
Model Number*
Catalog Number*
Lot Number090076
ID Number*
Device Expiration Date2008-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key858182
ManufacturerGE HEALTHCARE FINLAND OY
Manufacturer AddressKUORTANEENKATU 2 HELSINKI FI FIN-00510


Patients

Patient NumberTreatmentOutcomeDate
10 2006-09-07

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