MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR

Model Number	863065
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that vm6 us (b)(4) screen froze.Patient involvement is unknown.
Event or Problem Description
It was reported to philips that vm6 (b)(6) screen froze.The complaint device was not in use at the time that the issue was discovered.
Additional Manufacturer Narrative
This supplemental report is being submitted with reference to manufacturer's report 1218950-2022-00484 to update the final conclusion code.
Event or Problem Description
It was reported to philips that vm6 us34480960 screen froze.The complaint device was not in use at the time that the issue was discovered.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14655021
• Report Number: 1218950-2022-00484
• Device Sequence Number: 5550724
• Product Code: MHX
• UDI-Device Identifier: 00884838000056
• UDI-Public: 00884838000056
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

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
• Device Model Number: 863065
• Device Catalogue Number: 863065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 06/02/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/27/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2014
• 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
• Patient Sex: Unknown