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

Model Number 863066

Device Problems Display Difficult to Read (1181); Unexpected Shutdown (4019); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device powers on to color bar screen and then freezes and powers off.The device was not in use on a patient at the time of event, there was no patient involvement.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12590636
• MDR Text Key: 275225586
• Report Number: 8043836-2021-10014
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: 00884838000063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123900
• 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

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• 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