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

Model Number 863279

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 05/26/2021

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 audio failure in the monitor, speaker error.Patient involvement is unknown.There was no report of patient or user harm.

Event Description

The customer reported the problem of an audio failure in the monitor.Patient involvement is unknown.

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Type of Device: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11938839
• MDR Text Key: 254264504
• Report Number: 1218950-2021-10629
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (y/n): N
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• 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: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/26/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1