MAUDE Adverse Event Report: ORIDION MEDICAL 1987 LTD. MICROSTREAM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	015183
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pt developed hospital acquired pressure injury to left ear.May have been from the end tidal co2 monitoring (patient controlled analgesia (pca) tubing.The tubing is harder and less flexible than the regular oxygen tubing that we use.

• Brand Name: MICROSTREAM
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL 1987 LTD.; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 7929348
• Report Number: 7929348
• Device Sequence Number: 16643841
• Product Code: CCK
• UDI-Device Identifier: 10884521551978
• UDI-Public: (01)10884521551978
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/27/2018
• Report Date (Section F): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 015183
• Device Catalogue Number: 015183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/27/2018