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

Model Number 863073

Device Problems No Audible Alarm (1019); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/19/2021

Event Type  malfunction  

Event Description

The customer reported the problem of configuration setting in the monitor, as customer is seeking to have unit in continuous not spot check from its default settings.The device was not in use at time of event, there was no reported patient or user impact.

Event Description

The customer reported that they are receiving a speaker malfunction and a red error message stating audio failed.The device was not in use on a patient at the time of event, there was no adverse event reported.

• 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
• MDR Report Key: 11615532
• MDR Text Key: 243819294
• Report Number: 1218950-2021-10290
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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?: No
• Distributor Facility Aware Date: 03/19/2021
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1