MAUDE Adverse Event Report: INTELLIVUE MP70

Model Number 862451

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/08/2021

Event Type  malfunction  

Event Description

The customer called philips to report ¿issues with the arrhythmia alarms¿ on their mp70 bedside monitor.It is unknown if the device was in use at time of event, no adverse or patient impact was reported.

Event Description

The customer called philips to report ¿issues with the arrhythmia alarms¿ on their mp70 bedside monitor.It is unknown if the device was in use at time of event, no adverse or patient impact was reported.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• MDR Report Key: 12258650
• MDR Text Key: 264478726
• Report Number: 9610816-2021-10267
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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?: No
• Distributor Facility Aware Date: 07/08/2021
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2005
• 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