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

Model Number 866062

Device Problem Device Fell (4014)

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

Event Date 11/27/2022

Event Type  malfunction  

Event Description

Customer reported that when adjusting the monitor and mount, the mount fell off the wall.Customer felt that the mounting hardware should have supported the weight of the mx450 that was in use for patient monitoring.The device was in use on a patient.There was no report of patient or user harm.Customer refused onsite assistance from philips.Customer took responsibility to resolve, therefore, philips is unable to determine if the device failed to meet specifications.

• 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: 16301769
• MDR Text Key: 308838092
• Report Number: 9610816-2023-00055
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2020
• 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