MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2

Model Number 863278

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported noisy signal¿ message appears on cve monitor screen and when the monitor is turned on the message of "audio failure" appears.The device was not in use on a patient at the time of the event.

Event Description

The customer reported noisy signal¿ message appears on cve monitor screen and when the monitor is turned on the message of "audio failure" appears.The device was not in use on a patient at the time of the event.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Type of Device: SURESIGNS VS2+ NBP/SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 11719030
• MDR Text Key: 247094783
• Report Number: 1218950-2021-10411
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: 00884838028395
• Combination Product (y/n): N
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863278
• Device Catalogue Number: 863278
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/13/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1