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 05/18/2021

Event Type  malfunction  

Event Description

The customer reported that there's an audio failure and no sound comes out of it even though everything is plugged in properly.There was no reported patient or user impact.

• 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: daniel derochers ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 12013975
• MDR Text Key: 256770430
• Report Number: 8043836-2021-10008
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• 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: 863073
• Device Catalogue Number: 863073
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/18/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2007
• 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