MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4 NBP, SPO2; VITAL SIGNS MONITOR

Model Number 863283

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

Section e reporting institution phone # (b)(6).Section e reporter phone # (b)(6).

Event Description

Philips received a complaint on the suresigns vs4 nbp, spo2 sn (b)(6).Indicating a speaker malfunction error.The device was not in use on a patient at the time of the event, there was no patient involvement.The biomedical engineer was unable to replicate the fault reported by the clinician.A philips field service engineer (fse) went onsite to evaluate the device in question.When the fse tried to replicate the fault, he was unable to replicate the issue as well.The fse replaced the speaker as a precaution.Based on the information available and the testing conducted, the cause of the reported problem could not be confirmed.The device passed all testing and remains in use at the customer site.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: VITAL SIGNS MONITOR
• 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: 17959902
• MDR Text Key: 325976372
• Report Number: 1218950-2023-00787
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/28/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• 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