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

Model Number CS08651-02

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7441036
• MDR Text Key: 106258957
• Report Number: 8044004-2018-00007
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10884521551480
• UDI-Public: 10884521551480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1