MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 4 PATIENT MONITOR

Model Number	863063
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
The customer reported that the screen turns on and then freezes.It is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) in communication with the customer clinical engineer determined that the screen failed and required replacement.Nemo (non engineering material only) service was agreed upon for the replacement of the front panel.The replacement part was sent to the customer to resolve the issue.Based on the information available and the testing conducted, the cause of the reported problem was the front panel.The reported problem was confirmed.The customer was provided a replacement part to resolve the issue.

• Brand Name: SURESIGNS VM 4 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 4 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17830453
• Report Number: 1218950-2023-00705
• Device Sequence Number: 7247406
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Model Number: 863063
• Device Catalogue Number: 863063
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2014
• 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