MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS3 NBP, SPO2, TEMP

Model Number 863073

Device Problem High Readings (2459)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported the problem of spo2 readings inaccurately high.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

Event Description

The customer reported the problem of spo2 readings inaccurately high.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

• Brand Name: SURESIGNS VS3 NBP, SPO2, TEMP
• Type of Device: SURESIGNS VS3 NBP, SPO2, TEMP
• 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: 14932738
• MDR Text Key: 295640787
• Report Number: 1218950-2022-00557
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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: 863073
• Device Catalogue Number: 863073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2012
• 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