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

Model Number 866062

Device Problem No Audible Alarm (1019)

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

Event Date 04/16/2024

Event Type  malfunction  

Manufacturer Narrative

Section e reporting institution phone #: (b)(6).A philips field service engineer (fse) visited onsite and unable to confirm the reported issue ¿speaker error and no sound".The fse turned on the monitor and no error message appeared on the device and the fse confirmed that alarms are audible.The fse replaced the loudspeaker assembly in case the problem is intermittent.

Event Description

It was reported intellivue mx450 patient monitor displays a speaker malfunction error and no sound is coming from the device.The device was in use on a patient.There was no report of patient or user harm.

• 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
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 19172179
• MDR Text Key: 341201456
• Report Number: 9610816-2024-00224
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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: Health Professional
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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