MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS AIR MIXER 965; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Catalog Number 03802A

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problem Overdose (1988)

Event Date 07/19/2016

Event Type  malfunction  

Event Description

This blender was not blending oxygen - only delivering 100%.It was on patient and over-oxygenating them for 18 hours.Unknown outcome from receiving extra oxygen.

• Brand Name: AIR MIXER 965
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS; 2360 north palmer dr.; p.o. box 94517; schaumburg IL 60195
• MDR Report Key: 5971241
• MDR Text Key: 55391888
• Report Number: 5971241
• Device Sequence Number: 1
• Product Code: BZR
• 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: 07/26/2016,08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03802A
• Other Device ID Number: CEID 112874
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2016
• 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