MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4 NBP, SPO2

Model Number	863283
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suresigns vs4 nbp, spo2 had a defective loudspeaker.It is unknown if there was still sound coming from the device at the time of the event.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
E1: (b)(4).A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The following functional tests were performed: a field service engineer (fse) went onsite to evaluate the device and found that the speaker was defective.A quote for a replacement speaker was provided to the customer.Based on the information available, the cause of the reported problem was the speaker.The reported problem was confirmed.The customer was provided with a quote for a replacement speaker.The customer is taking responsibility to correct/repair the device.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported that the suresigns vs4 nbp, spo2 had a defective loudspeaker.A good faith effort (gfe) was performed to clarify if the speaker produced sound at the time of the event, but the information was unknown.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Common Device Name: SURESIGNS VS4 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: 20651616
• Report Number: 1218950-2024-00796
• Device Sequence Number: 8219081
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163649
• 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
• Report Date (Section B): 02/17/2025

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: 863283
• Device Catalogue Number: 863283
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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