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

Model Number	863068
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
The customer reported that the audio module not functioning from the device.It is unknown if the device was in use at time of event, there was no adverse event reported.
Event or Problem Description
The customer reported that the audio module not functioning from the device.It is unknown if the device was in use at time of event, there was no adverse event reported.The customer advised that the monitor was under use, so the customer could not troubleshoot with the device.The customer advised they would call back when they become available for investigation.Philips is unable to confirm the final disposition of the device because the customer advised that the monitor was under use at the time and that they would call back.

• 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: 16282196
• Report Number: 1218950-2023-00062
• Device Sequence Number: 12016882
• Product Code: MHX
• UDI-Device Identifier: 00884838000087
• UDI-Public: 00884838000087
• 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: 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: 863068
• Device Catalogue Number: 863068
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2013
• 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