MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR200)

Model Number	866120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a laceration in the pressure area of a right toe using sensor.The device was in use on patient at time of event, there was an injury reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter phone # (b)(6).Reporting institution phone # (b)(6).Reporting address state (b)(6).
Additional Manufacturer Narrative
The customer reported a laceration in the pressure area of a right toe of a patient using a sensor.Additional information gathered clarified the injury in that the word 'laceration' was used to describe the zone of pressure from the clip, which caused redness on the right toe.A gel was applied to the toe, but no further intervention was required.Based on this information the customers device issue would not be considered a serious injury.The case is now considered non-reportable.

• Brand Name: EXPRESSION PATIENT MONITOR (MR200)
• Common Device Name: EXPRESSION PATIENT MONITOR (MR200)
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: feng she ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 19320876
• Report Number: 1051786-2024-00007
• Device Sequence Number: 7659184
• Product Code: MWI
• UDI-Device Identifier: 00884838033764
• UDI-Public: 00884838033764
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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?: No
• Device Model Number: 866120
• Device Catalogue Number: 866120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown