MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM

Model Number	CS08651-03
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/18/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device did not alarm.The customer reported that the device alarmed throughout the night, but when the patient was found expired, the monitor had not been alarming.It was reported that the device was connected to another system via wifi, wherein they need to see if there is an intermittent wifi connection issue.

• Brand Name: MICROSTREAM
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 7981436
• Report Number: 8044004-2018-00010
• Device Sequence Number: 16180117
• Product Code: MHX
• UDI-Device Identifier: 10884521722927
• UDI-Public: 10884521722927
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS08651-03
• Device Catalogue Number: CS08651-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death