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

Model Number	863065
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the monitor on the complaint device was frozen and requested support.It is unknown if the complaint device was in clinical use at the time that the issue was discovered as this information was not provided.There was no adverse event or patient harm reported.
Event or Problem Description
The customer contacted the customer care solution center and alleged that the monitor on the complaint device freezes when adjusting parameters and that the screen had frozen.The customer then requested support.It was originally unknown if the complaint device was in clinical use at the time that the issue was discovered as this information was not provided.Information was later provided which indicated that the complaint device was in use at the time that this issue was discovered.There was no adverse event or patient harm 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
• MDR Report Key: 11921333
• Report Number: 1218950-2021-10622
• Device Sequence Number: 845430
• 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

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: No Information
• Device Model Number: 863065
• Device Catalogue Number: 863065
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/27/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1