MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION

Model Number CS08657-01

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.This report is associated to a similar product sold in the us - 510(k) number k892432.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, there was a black smoke appears in the unit when it was plugged.The customer indicated that there was no patient involvement.

Manufacturer Narrative

Correction: (udi).Evaluation summary one sample was received for evaluation, a visual inspection was conducted and it was observed that the ferrite core pieces were found from damaged component l1 on the ac/dc pcba.Heat sink screw for u7 had small black marks and damage consistent with arcing.Ferrite core pieces were inspected and discoloration consistent with heat was found.Dc/dc pcba was removed.Potential root cause determined to be broken ferrite pieces causing arcing between the dc/dc pcba u7 heat sink screw and the chassis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ORIDION
• 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: 7331292
• MDR Text Key: 102345388
• Report Number: 8044004-2018-00003
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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
• Device Operator: Health Professional
• Device Model Number: CS08657-01
• Device Catalogue Number: CS08657-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/10/2018
• 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