MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI

Model Number	863276
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a speaker malfunction message, and no sound could be heard.It is unknown if the device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
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.Section e reporting institution phone #: (b)(6).Section e reporter phone #:(b)(6).
Additional Manufacturer Narrative
The philips bench repair technician (brt) found that after starting the device, there is no sound and a message about the speaker failure appears.During the repair, the brt performed a positive speaker test and the sound was present.The device was monitored and further tested with no issues.The reported problem was confirmed and was resolved by performing positive speaker testing which involves sending a series of sounds to the speaker to ensure it is functioning.The device was found to be operational and returned to the customer.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 VSI
• Common Device Name: SURESIGNS VSI
• 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: 22311648
• Report Number: 1218950-2025-000368
• Device Sequence Number: 15667818
• Product Code: DSK
• UDI-Device Identifier: 00884838028371
• UDI-Public: (01)00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 07/24/2025

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: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown