MAUDE Adverse Event Report: DATEX-OHMEDA, INC. EXCEL 210 SE; ANESTHESIA GAS MACHINE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The year of manufacture is 1992, month could not be determined.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, during the preoperative checkout, it was noted that the oxygen/nitrous oxide proportioning system was not accurate.There was no report of patient involvement.

Manufacturer Narrative

The hospital readjusted the oxygen sprocket screw, and resolved the reported complaint.No parts were replaced; no samples were made available for analysis.The exact root cause cannot be determined.

• Brand Name: EXCEL 210 SE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3079
• MDR Report Key: 4997467
• MDR Text Key: 24115483
• Report Number: 2112667-2015-00099
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K863207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1