MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem Failure to Transmit Record (1521)

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

Event Date 06/19/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the problem of sending false information to the central monitor.Patient involvement is unknown.

Manufacturer Narrative

H3 other text : customer resolved.

Event Description

The customer contacted the customer care solutions center(ccsc) for assistance.According to the case closure notes, the issue was resolved by the customer and no work performed by philips.Additional information was requested on how the issue was resolved.The customer clarified that the false information was when it is sending information from a different patient mixed with the correct patient vitals.The customer stated that he had worked with his facility's it department to resolve this issue.The customer had worked with his facility's department to resolve the reported issue.Based on the resolution, this is not an indication of the vs4 malfunctioning but it is within the customer's it department.A search in servicemax found no further related calls.The device remains in use at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12180401
• MDR Text Key: 261934562
• Report Number: 1218950-2021-10725
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

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
• Distributor Facility Aware Date: 06/19/2021
• Initial Date Manufacturer Received: 06/19/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 06/19/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1