MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE MP70

Model Number 862451

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 03/03/2021

Event Type  malfunction  

Event Description

The customer reported their mp70 intellivue patient monitor is not alarming correctly.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• 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 street; cambridge, MA 02141
• MDR Report Key: 11585944
• MDR Text Key: 243170195
• Report Number: 9610816-2021-10052
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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: No Information
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/03/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2008
• 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