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	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site and determined the speaker the did not work, and a loudspeaker alarm was triggered.The fse found that it was disassembled, and the speaker connector was loose.The fse reconnected the speaker connector cable.The cause of the reported problem was the connection of the speaker cable.The reported problem was confirmed.No part was replaced.The investigation concludes that no further action is required at this time.Reporting institution phone: (b)(6).Reporter phone: not provided.
Event or Problem Description
It was reported the speaker does not work and a loudspeaker alarm is triggered, the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18886136
• Report Number: 1218950-2024-00154
• Device Sequence Number: 20730697
• Product Code: DSJ
• UDI-Device Identifier: 00884838028890
• UDI-Public: 00884838028890
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2017
• 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