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

Model Number	CS08651-02
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The technician verified customer complaint of a burning smell.Unit was picked up and a small rattling noise was heard.Burning smell was observed with the unit fully assembled.No attempts were made to power on the device.Unit was disassembled and when the rear housing was removed, a small piece of ferrite was found loose inside the unit.Ferrite was broken off of the ac/dc l1 inductor.Further disassembly found that the burning smell was due to a piece of the broken ferrite becoming wedged between the dc/dc pcba and the chassis, causing a short.Burn marks were found on the chassis and the dc/dc pcba.Both ac/dc and dc/dc pcbas were removed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the device had a burning electrical smell and battery icon was in red.The customer indicated there was no patient involvement.

• Brand Name: MICROSTREAM
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 7441036
• Report Number: 8044004-2018-00007
• Device Sequence Number: 1092274
• Product Code: CCK
• UDI-Device Identifier: 10884521551480
• UDI-Public: 10884521551480
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: CS08651-02
• Device Catalogue Number: CS08651-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1