MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 4 PATIENT MONITOR

Model Number	863063
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the device does not sound an alarm.Patient involvement is unknown.
Event or Problem Description
It was reported to philips that suresigns vm 4 patient monitor did not sound an alarm, but normal sound was present.The device was not in use on a patient at the time the issue was discovered.There was no adverse event or patient harm reported.The medical technician found the device which has not been used for a long time in the storage room and gave it to the technician for security check.The technician checked and detected that the monitor did not give an alarm.The device is currently in the workshop.The philips representative replaced the main board to resolve the issue.The cause of the event was the main board.The device remained on site.

• 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: 15319666
• Report Number: 1218950-2022-00849
• Device Sequence Number: 20209951
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 863063
• Device Catalogue Number: 863063
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2011
• 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