MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2

Model Number	863276
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.E1: reporting institution phone: (b)(6).E1: reporter phone (b)(6).
Event or Problem Description
It was reported the suresigns vsi nbp/spo2 monitor did not generate alarms.The device was in use on a patient.There was a report of patient harm.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and could confirm that it was a main board issue.The engineer provided their analysis findings to the customer however the customer did not accept the service of main board to be replaced.Based on the information available and the testing conducted, the cause of the reported problem was a defective mainboard.The reported problem was confirmed.
Event or Problem Description
It was reported the suresigns vsi nbp/spo2 monitor did not generate alarms.The device was in use on a patient.There was no report of patient harm.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and confirmed the cause of the reported problem was defective mainboard.The reported problem was confirmed.The engineer provided their analysis findings however the customer did not accept the service of main board to replaced.If additional information is received the complaint file will be reopened.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - NBP/SPO2
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18375122
• Report Number: 1218950-2023-00963
• Device Sequence Number: 12691005
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112652
• 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: 863276
• Device Catalogue Number: 863276
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 03/15/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/04/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2014
• 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