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

Model Number 863278

Device Problem Defective Component (2292)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report (b)(6).

Event Description

The customer reported speaker malfunction.There was no further information provided by the customer.Additional information is being requested.There was no reported patient or user harm.

Event Description

The customer reported the problem of speaker malfunction.Additional information received that the speaker malfunction error was seen with alarm.There was no reported patient or user harm.

• 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: 11376220
• MDR Text Key: 241399011
• Report Number: 1218950-2021-10021
• 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

• Date FDA Received: 02/24/2021
• 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?: No
• Distributor Facility Aware Date: 02/11/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1