MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 8 PATIENT MONITOR

Model Number	863066
Medical Device Problem Codes	No Audible Alarm (1019); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Customer reported an unspecified speaker malfunction.The device was not in use on a patient at the time of the event.
Event or Problem Description
Customer reported there was a speaker malfunction.Lack of audio as well as a visual speaker inop message was confirmed.The appropriate part was replaced and the unit is now operational.The device was not in use on a patient at the time of the event.

• Brand Name: SURESIGNS VM 8 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 8 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: 16214744
• Report Number: 1218950-2023-00030
• Device Sequence Number: 4341503
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: 00884838000063
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 863066
• Device Catalogue Number: 863066
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2011
• 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