MAUDE Adverse Event Report: INVIVO CORPORATION PHILIPS EXPRESSION MR200; PHYSIOLOGICAL PATIENT MONITOR

Model Number	866120
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 (b)(6) reported that one of the device's casters will not remain locked.The device was not in use on a patient.
Additional Manufacturer Narrative
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.H3 other text : the caster was discarded.

• Brand Name: PHILIPS EXPRESSION MR200
• Common Device Name: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 9786768
• Report Number: 1051786-2020-00007
• Device Sequence Number: 14151618
• Product Code: MWI
• UDI-Device Identifier: 00884838033764
• UDI-Public: (01)00884838033764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 866120
• Device Catalogue Number: 866120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1