MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP60

Model Number 862450

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

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

Event Date 07/14/2021

Event Type  malfunction  

Event Description

The customer called philips to report ¿the alarm disappears¿ on their mp60 bedside monitor.The device was not in use on a patient at the time of event, there was no adverse event reported.

Event Description

The customer called philips to report ¿the alarm disappears¿ on their mp60 bedside monitor.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE MP60
• Type of Device: INTELLIVUE MP60
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12225752
• MDR Text Key: 263428809
• Report Number: 9610816-2021-10254
• 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: foreign,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862450
• Device Catalogue Number: 862450
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/14/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1