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	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the suresigns vs4 monitor was presented with a speaker malfunction inop error.The device was not in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer and confirmed the reported issue ¿speaker malfunction inop error".It was unknown whether speaker was able to produce sound.The rse advised the customer to clear the speaker malfunction error and to perform an audio test.The biomed verified that the speaker malfunction error is gone and heard 3 distinctive tones.The device was working to its specifications after the error message was cleared.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : remote support engineer talked to customer.

• 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: 19308021
• Report Number: 1218950-2024-00349
• Device Sequence Number: 17789571
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2013
• 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