MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO CORPORATION; PATIENT MONITOR

Model Number	865353
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that no alarm sound was coming from the device.The device was not in use on a patient.There was no reported patient impact.

• Brand Name: INVIVO CORPORATION
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 8392852
• Report Number: 1051786-2019-00012
• Device Sequence Number: 1858732
• Product Code: DQA
• UDI-Device Identifier: 00884838012585
• UDI-Public: (01)00884838012585
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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
• Operator of Device: Health Professional
• Device Model Number: 865353
• Device Catalogue Number: 865353
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1