MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 8 PATIENT MONITOR

Model Number	863066
Medical Device Problem Codes	Display Difficult to Read (1181); Unexpected Shutdown (4019); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the device powers on to color bar screen and then freezes and powers off.The device was not in use on a patient at the time of event, there was no patient involvement.

• Brand Name: SURESIGNS VM 8 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 8 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12590636
• Report Number: 8043836-2021-10014
• Device Sequence Number: 4103172
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: 00884838000063
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 863066
• Device Catalogue Number: 863066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1