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Adverse Event Report

DATEX-OHMEDA GMS ABSORBER CARBON DIOXIDE ABSORBER   back to search results
Model Number GMS ABSORBER
Event Type  Malfunction  
Event Description

Customer reported difficulty ventilating the pt in the bag or ventilator mode. There was no reported pt injury. Investigation/conclusion: the datex-ohmeda svc rep inspected the equipment and found that the gms absorber had a broken truarc ring within the selector valve switch. The exact cause of the broken ring could not be determined. This is the first mdr involving a gms absorber wherein the cause was a broken truarc ring out of an installed base of approx 51,000 units.

 
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Brand NameGMS ABSORBER
Type of DeviceCARBON DIOXIDE ABSORBER
Baseline Brand NameGMS ABSORBER
Baseline Generic NameCARBON DIOXIDE ABSORBER
Baseline Catalogue Number0309-0170-800
Baseline Model NumberGMS ABSORBER
Baseline Device FamilyCARBON DIOXIDE ABSORBER
Baseline Device 510(K) NumberK852071
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/01/1985
Manufacturer (Section F)
DATEX-OHMEDA
ohmeda drive
madison WI 53707
Manufacturer (Section D)
DATEX-OHMEDA
ohmeda drive
madison WI 53707
Manufacturer (Section G)
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
3030 ohmeda drive
madison WI 53718 6794
Manufacturer Contact
cathy johnson
ohmeda drive
madison , WI 53707
(608) 221 -1551
Device Event Key193040
MDR Report Key198714
Event Key186727
Report Number2112667-1998-00090
Device Sequence Number1
Product CodeBSF
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberGMS ABSORBER
Device Catalogue Number0309-0170-800
Device LOT NumberNONE
OTHER Device ID NumberNONE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/1998
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/20/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1992
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Database last updated on January 30, 2009

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