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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC (GE) ASSY-MSN, NEEDLE VALVE KIT N2O, FINISHED GOOD-MAKE N2O NEEDLE VALVE

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DATEX-OHMEDA, INC (GE) ASSY-MSN, NEEDLE VALVE KIT N2O, FINISHED GOOD-MAKE N2O NEEDLE VALVE Back to Search Results
Model Number 1006-8345-000
Device Problems Defective Component (2292); Failure to Advance (2524)
Patient Problem No Information (3190)
Event Date 06/12/2018
Event Type  Malfunction  
Event Description

During the routine preventative maintenance of an astevia mri gas machine it was noticed the device was failing the proportioning system verification test. The biomedical engineering tech performing the preventative maintenance identified that the nitrous oxide needle valve required replacement. A new datex-ohmeda (ge) needle valve was ordered. When the package was opened the tech noticed that the needle was not stable and could easily be moved within its casing, indicating that the valve was defective. The technician then ordered a second needle valve. The second needle valve, which had the same lot number as the first, when opened would not turn to advance the needle. A third valve of the same lot number was sent. The third valve would also not rotate to advance the needle. Three defective needle valves, all of the same lot number, were shipped to our biomedical engineering department and failed directly out of the box. Per site reporter: we intend to arrange for the return of these valves for failure analysis.

 
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Brand NameASSY-MSN, NEEDLE VALVE KIT N2O, FINISHED GOOD-MAKE
Type of DeviceN2O NEEDLE VALVE
Manufacturer (Section D)
DATEX-OHMEDA, INC (GE)
3030 ohmeda dr.
madison WI 53718
MDR Report Key7780260
MDR Text Key117010034
Report Number7780260
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1006-8345-000
Device Catalogue Number1006-8345-000
Device LOT Number09APR2018/BB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2018
Event Location Hospital
Date Report TO Manufacturer08/14/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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