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

Model Number	CS08651-02
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic receive a report that a small puff of smoke was observed at the bottom of the unit and then the unit did not turn on.There was no patient involvement in this event.

• Brand Name: ORIDION MEDICAL
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 7105880
• Report Number: 8044004-2017-05012
• Device Sequence Number: 13818339
• Product Code: CCK
• UDI-Device Identifier: 10884521551480
• UDI-Public: 10884521551480
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS08651-02
• Device Catalogue Number: CS08651-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1