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

Model Number 863283

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the device in question.The fse indicated during an evaluation of the system that the system speaker and mainboard are faulty.The philips field service engineer (fse) replaced the system speaker and main board to resolve the device issue.The device was operational after repairs were completed and the device was returned to the customer.

Event Description

The customer reported that the speaker has no sound.The device was not in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: 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: 18716282
• MDR Text Key: 336517782
• Report Number: 1218950-2024-00102
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: GI
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1