MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR

Model Number	863065
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient monitoring was no longer possible.No parameters could be changed, alarms were not displayed or reported.The monitor could only be operated again after a hardware reset.At the time of the event, ecg and spo2 sensors were connected.The device was taken out of service.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to the (b)(6) competent authority ((b)(4) user report (b)(4)) that when activating the respiration display, the screen "freezes" permanently.The device was in use on a patient.There was no report of patient or user harm.
Event or Problem Description
It was reported to germay competent authority (bfarm user report (b)(4)) that when activating the respiration display, the screen "freezes" permanently.Patient monitoring was no longer possible.No parameters could be changed, alarms were not displayed or reported.The monitor could only be operated again after a hardware reset.At the time of the event, ecg and spo2 sensors were connected.The device was taken out of service.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12852023
• Report Number: 1218950-2021-11117
• Device Sequence Number: 5094799
• Product Code: MHX
• UDI-Device Identifier: 00884838000056
• UDI-Public: 00884838000056
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: Other
• Device Model Number: 863065
• Device Catalogue Number: 863065
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2014
• 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