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

Model Number 863283

Device Problem High Readings (2459)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

The customer reported the problem of device displays spo2 inaccurate high readings.It is unknown if device was in use at time of event, no adverse event or patient harm was reported.

• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14086521
• MDR Text Key: 289095535
• Report Number: 1218950-2022-00327
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2017
• 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