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

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.

• Brand Name: ASSY-MSN, NEEDLE VALVE KIT N2O, FINISHED GOOD-MAKE
• Type of Device: N2O NEEDLE VALVE
• Manufacturer (Section D): DATEX-OHMEDA, INC (GE); 3030 ohmeda dr.; madison WI 53718
• MDR Report Key: 7780260
• MDR Text Key: 117010034
• Report Number: 7780260
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1006-8345-000
• Device Catalogue Number: 1006-8345-000
• Device Lot Number: 09APR2018/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 FDA: 08/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1