MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 8 PATIENT MONITOR

Model Number 863066

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

The customer contacted the customer care solution center and alleged an audio failure on the speaker of the complaint device.It was also reported that an spo2 failure had occurred and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: SURESIGNS VM 8 PATIENT MONITOR
• Type of Device: SURESIGNS VM 8 PATIENT MONITOR
• 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 street; cambridge, MA 02141
• MDR Report Key: 11379024
• MDR Text Key: 233555706
• Report Number: 8043836-2021-00001
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: 00884838000063
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K123900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• 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: 863066
• Device Catalogue Number: 863066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2012
• 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