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	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).
Event or Problem Description
The customer reported a speaker malfunction, no alarm coming from the device.It is unknown if the device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips field service engineer (fse) went for onsite service at the customer side and performed diagnostic/functional testing on the device.Results of functional testing indicate that the device was not producing an alarm sound.After the replacement of the main board the device returned into service.
Event or Problem Description
The customer reported a speaker malfunction, no alarm coming from the device.The device was not in use at time of event, there was no adverse event reported.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18737587
• Report Number: 1218950-2024-00101
• Device Sequence Number: 6934364
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: 00884838028395
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• 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: Health Professional
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2018
• 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