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

Model Number	863063
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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.Initial reporter phone # (b)(6).
Event or Problem Description
The customer requested a quote for a loudspeaker.It is unknown if the device was 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) remotely interviewed the customer who was onsite.The biomedical engineer reported the loudspeaker needs to be replaced.The rse could not confirm if the speaker produced sound.The customer did not approve the quote for onsite repair of the device.
Event or Problem Description
Additional information was received that the device was not in clinical use.

• 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: 16950101
• Report Number: 1218950-2023-00340
• Device Sequence Number: 12515792
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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 Facility
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2013
• 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