MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ALADIN II; ANESTHESIA GAS MACHINE

Model Number	1100-9025-000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ge healthcare was contacted by baxter healthcare portugal regarding this event.No further diagnostic or site correction information is available.
Event or Problem Description
This report summarizes 1 malfunction event.A review of the event indicated that model 1100-9025-000 anesthesia gas machine experienced a malfunction resulting in light anesthesia causing the patient to wake up during the procedure.The report was received from a single source.The reported event did involve a patient.There was no patient information available.

• Brand Name: ALADIN II
• Common Device Name: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8535647
• Report Number: 2112667-2019-00163
• Device Sequence Number: 373803
• Product Code: BSZ
• UDI-Device Identifier: 00840682100205
• UDI-Public: 010084068210020521
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 1100-9025-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1