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

Model Number 863073

Device Problem No Audible Alarm (1019)

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

Event Date 09/20/2021

Event Type  malfunction  

Event Description

The customer reported that the monitor was giving audio errors.Speaker was replaced but no sound is being made by the monitor.The device was not in use on a patient at the time of event, there was no patient involvement.

• 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: 12624983
• MDR Text Key: 276203138
• Report Number: 8043836-2021-10015
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2011
• 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