MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. NARKOMED 6400 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2018

Event Type  malfunction  

Event Description

Patient was in prone position, under general anesthesia for lumber laminectomy.During procedure, the anesthesia machine ventilator malfunctioned and failed.Anesthesia crna began to ventilate by hand, anesthesia doctor and technicians were called into the room to assist while an alternate anesthesia machine was brought into the room and put into operation.Thankfully this occurred at a time of day that allowed for an alternate machine to be readily available as nearby or's were not in use at the time.The anesthesia machines are preventively maintained twice a year ((b)(6)).Machine control# (b)(4) had its preventive maintenance performed on in (b)(6) of this year and last summer.At the time of the failure, the machine was taken out of service and replaced with a spare anesthesia machine.

• Brand Name: NARKOMED 6400 ANESTHESIA SYSTEM
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 7501938
• MDR Text Key: 107876258
• Report Number: 7501938
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: MEDICAL ENGINEERING CONTROL #
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR