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

Model Number 866062

Device Problem Battery Problem (2885)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device's battery burned.This is not applicable as there was no patient involvement.

Event Description

It was reported to philips that the device's battery burned.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• 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: 12302893
• MDR Text Key: 265876387
• Report Number: 9610816-2021-10287
• 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
• Device Lot Number: 1320
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1