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Adverse Event Report

DATEX-OHMEDA GMS ABSORBER CARBON DIOXIDE ABSORBER   back to search results
Model Number GMS ABSORBER
Event Date 03/20/2001
Event Type  Malfunction  
Event Description

Customer reported difficulty in operating the bag-to-vent switch. There was no reported pt injury. Datex-ohmeda's investigation into the reported occurrence is still ongoing. A f/u report will be issued when the investigation has been completed.

 
Manufacturer Narrative

Investigation/conclusion: the datex-ohmeda service representative returned the unit's e-rings from the bag-to vent switch for investigation. The parts were inspected and found to be cracked, the exact cause of the which could not be determined. This is the first mdr within the last 12 months involving a gms absorber wherein the cause was a cracked e-ring out of an installed based of approximately 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 dr.
madison WI 53707
Manufacturer (Section D)
DATEX-OHMEDA
ohmeda dr.
madison WI 53707
Manufacturer Contact
cathy johnson, specialist
ohmeda dr
madison , WI 53707
(608) 221 -1551
Device Event Key315527
MDR Report Key326080
Event Key306857
Report Number2112667-2001-00023
Device Sequence Number1
Product CodeBSF
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/20/2001,04/05/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2001
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
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/04/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/20/2001
Event Location Hospital
Date Manufacturer Received03/20/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1989
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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