MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	010582
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the prong of the cannula partially came off.The customer indicated that there was no patient injury.

• Brand Name: MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 7340162
• Report Number: 8044004-2018-00004
• Device Sequence Number: 137232
• Product Code: CCK
• UDI-Device Identifier: 20884521552002
• UDI-Public: 20884521552002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 010582
• Device Catalogue Number: 010582
• Device Lot Number: Q170100484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1