MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC 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	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported there was an audio speaker issue in the monitor.The device was in clinical use at the time of the reported event.There was no patient involvement or harm reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported there was an audio speaker issue in the monitor.The device was in clinical use at the time of the reported event.There was no patient involvement or harm reported.
Event or Problem Description
The customer reported an audio speaker issue in the monitor.The device was in clinical use at the time the issue was discovered.  there was no adverse event or patient harm reported.  remote service was provided and it was determined the speaker issue was caused by device configuration.After monitor reconfiguration the device was returned to service.
Additional Manufacturer Narrative
The customer reported an audio speaker issue in the monitor.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.Remote service was provided and it was determined the speaker issue was caused by device configuration.After monitor reconfiguration the device was returned to service.

• Brand Name: SURESIGNS VM 4 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 4 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15753330
• Report Number: 1218950-2022-00967
• Device Sequence Number: 17721494
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• 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,Followup,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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 10/11/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/07/2022; 01/04/2023
• Date Device Manufactured: 10/14/2009
• 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