MAUDE Adverse Event Report: INVIVO CORPORATION PHILIPS EXPRESSION INFORMATION PORTAL (IP5); PHYSIOLOGICAL PATIENT MONITOR

Model Number	865471
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer claimed that the device lost audio sound.There was no patient involved.
Additional Manufacturer Narrative
H10: the customer was shipped a 453564304191 (assy,open frame computer,19in,refurb.) in order to resolve the issue.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PHILIPS EXPRESSION INFORMATION PORTAL (IP5)
• Common Device Name: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 9995493
• Report Number: 1051786-2020-00024
• Device Sequence Number: 2785149
• Product Code: MWI
• UDI-Device Identifier: 00884838031890
• UDI-Public: (01)00884838031890
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K121424
• 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,Followup
• Report Date (Section B): 04/21/2020

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: 865471
• Device Catalogue Number: 865471
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1