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

Model Number	863063
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the customer complaint of temperature variation, sporadic delay of reading.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Additional Manufacturer Narrative
(b)(6).A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the customer complaint of temperature variation, sporadic delay of reading.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 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13176090
• Report Number: 1218950-2022-00013
• Device Sequence Number: 19973787
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: 00884838000032
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Device Model Number: 863063
• Device Catalogue Number: 863063
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2015
• 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