MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM6; SURESIGNS VM 6 PATIENT MONITOR

Model Number	SURESIGNS VM 6 PATIENT MONITOR
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the suresigns vm 6 patient monitor displays a speaker malfunction inop error message and is unable to produce sound.The device was not in use on a patient at the time of the event, there was no patient involvement.
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.Customer information, full address line: (b)(6).Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and was informed that the customer performed a self check and cleaned the speaker of the device which resolved the issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: SURESIGNS VM6
• Common Device Name: SURESIGNS VM 6 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 21749939
• Report Number: 1218950-2025-000200
• Device Sequence Number: 8079662
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: (01)00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: SURESIGNS VM 6 PATIENT MONITOR
• Device Catalogue Number: 863064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2017
• 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