MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM

Model Number CS08657-02

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided indicates that the sample is expected to be returned for analysis.If the sample is returned, a summary of the analysis will be provided in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report from a biomedical engineer where it was initially reported that the unit was dropped and had a damaged front case on the display.The customer called back on the same day and provided information that alleged that the unit started smoking when connected to ac power and a foul odor came from the device.No complication to the end user was reported.

Manufacturer Narrative

The customer complaint of faint tones was confirmed.The defective main pcb was replaced.Repair including function testing to test protocol was performed and the unit passed all testing.The unit was reset to standard/ factory settings.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROSTREAM
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6386450
• MDR Text Key: 69645676
• Report Number: 8044004-2017-05000
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS08657-02
• Device Catalogue Number: CS08657-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• 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