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

Model Number 863283

Device Problem Sparking (2595)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

A philips biomedical equipment technician went to the customer site to evaluate the device and identified that power cable was pulled halfway away from the vs4 device, possibly causing it to short.The biomed resecured the connection before plugging the unit back.The biomed could not duplicate the reported problem.Based on the information available and the testing conducted, the cause of the reported problem was user error and not a device malfunction.The reported problem was not confirmed.No part was replaced.The investigation concludes that no further action is required at this time.Reporting institution phone: n/a reporter phone: n/a.

Event Description

It was reported the vitals machine emitted sparks from the outlet.The device was not in use on a patient at the time of 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: 19154278
• MDR Text Key: 340731303
• Report Number: 1218950-2024-00285
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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