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

Model Number	863064
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a speaker malfunctioning error and no sound was being emitted from the device.The device was not in clinical use at the time of the event.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke by telephone support to the customer biomed and determined the device speaker assembly would require replacement.The customer was provided with a speaker assembly for replacement.The device remains at the customer site.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18578713
• Report Number: 1218950-2024-00051
• Device Sequence Number: 7852395
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: 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: 863064
• Device Catalogue Number: 863064
• 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: 01/20/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2012
• 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