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

Model Number	863278
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the equipment is alarming "audio error".No patient harm was reported.
Additional Manufacturer Narrative
E1: reporter institution phone number (b)(6).E1: reporter phone number (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The following functional tests and communication were performed: a fse (field service engineer) visited onsite and confirmed the reported problem.The fse found out that motherboard was defective due to which device was not producing sound and replaced the part to resolve the issue.Device was working as intended after the replacement.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18959361
• Report Number: 1218950-2024-00213
• Device Sequence Number: 19968675
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: 00884838028395
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,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: 863278
• Device Catalogue Number: 863278
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown