MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

It was reported that the monitor will give an audible alarm after which the alarm continues continuously.The device was not used for patient monitoring at the time of the alleged malfunction.

Event Description

It was reported that the monitor will give an audible alarm after which the alarm continues continuously.The device was not used for patient monitoring at the time of the alleged malfunction.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 11406972
• MDR Text Key: 242717846
• Report Number: 9610816-2021-10010
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• PMA/PMN Number: K130849
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/23/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1