MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2

Model Number	863278
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the suresigns vs2+ nbp/spo2 monitor indicating the system displayed a speaker malfunction.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the device in question.The fse indicated during an evaluation of the system that the system displays a speaker malfunction.The fse confirmed with the customer that philips solution center was called for parts number and ordered parts.He philips field service engineer (fse) confirmed the customers device issue and confirmed with the customer that philips solution center was called for parts number and ordered parts.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Common Device Name: SURESIGNS VS2+ 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19529727
• Report Number: 1218950-2024-00432
• Device Sequence Number: 20759336
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: 00884838028395
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 863278
• Device Catalogue Number: 863278
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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