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

Model Number	863279
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the equipment displays an audio failure warning.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the speaker assembly.After speaker replacement the device was returned to functional use with no further issues identified.The device remains at the customer site.No further investigation or action is warranted at this time.
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the devices in question.The fse confirmed the computer's speaker was replaced because the computer displayed the following "audio failure" message.A good faith effort to obtain additional information regarding the event was submitted on (b)(6) 2023.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Philips received a complaint on the suresigns vs2+ nbp/spo2/wireless sn (b)(6) indicating audio failure.The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Common Device Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• 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: 17440136
• Report Number: 1218950-2023-00522
• Device Sequence Number: 2531543
• Product Code: DXN
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 863279
• Device Catalogue Number: 863279
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2014
• 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