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

Model Number	863283
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
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.(b)(6).
Event or Problem Description
It was reported that there was no alarm sound.It is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
A quote was provided to the customer for philips to perform testing of the device.However, there was no response to the quote; therefore, no work was able to be performed.Based on the information available, the cause of the reported problem was unable to be determined.Philips was unable to confirm the final disposition of the device, because the customer was considered to have refused service, due to not responding to the service quote.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 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: 20032096
• Report Number: 1218950-2024-00595
• Device Sequence Number: 3023864
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2018
• 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