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

Model Number 863278

Device Problem No Audible Alarm (1019)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

The customer reported that the loud speaker doesn't work anymore.The device was not in use on a patient at the time of event, there was no adverse event reported.

Event Description

The customer reported that the loud speaker doesn't work anymore.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Type of Device: SURESIGNS VS2+ NBP/SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12241801
• MDR Text Key: 264040064
• Report Number: 1218950-2021-10760
• 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: foreign,health professional,u
• 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: 863278
• Device Catalogue Number: 863278
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/19/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1