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
• 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

0 Patients were 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

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• 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: Unkown