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

Model Number 863283

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The customer reported that it shows wrong saturations.There was no reported patient impact / injury.

• 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
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11393426
• MDR Text Key: 234045064
• Report Number: 1218950-2021-10042
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2021
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1