MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2

Model Number	863276
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) remotely interviewed the customer who was onsite.The customer confirmed at start up the device displayed an inopertive message: echec audio.The customer also reported no alarm sounds were present and that it was impossible to cancel the alarms.The customer checked the speaker connection, and the speaker was securely plugged in.It was concluded there was a defect in the loudspeaker.The customer wished to order a new one for replacement as part of the contract.The rse provided the customer with a replacement speaker to resolve the issue.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.(b)(6).
Event or Problem Description
The customer reported that the device displays a message indicating audio failure and there are no alarm sounds.The device was not in use.There was no report of patient or user harm.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - 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: 17624279
• Report Number: 1218950-2023-00604
• Device Sequence Number: 17988388
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2017
• 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