MAUDE Adverse Event Report: GE HEALTHCARE; GAS-MACHINE, ANESTHESIA

Model Number 1011-9000-00

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Reset Problem (3019)

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

Event Date 01/14/2016

Event Type  Injury  

Event Description

Anesthesia machine was malfunctioning.After operating room case is finished, the start/end case button would freeze and anesthesia tech was unable to reset machine for next case.The only way to reset machine was to turn machine off with knob.

• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE; 9900 w innovation drive; mail stop: rp-2138; wauwatosa, WI 53226
• MDR Report Key: 5491665
• MDR Text Key: 40058367
• Report Number: 5491665
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-9000-00
• Device Catalogue Number: 1011-9000-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1