MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problems Fracture (1260); Device Fell (4014)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the holder (mount) on the wall side the patient monitor broke and the holder and monitor crashed with significant damage.It is unknown if the device was in use at time of event, and there was no adverse event reported.

Manufacturer Narrative

Philips received a complaint on the intellivue mx750 patient monitor sn (b)(6) indicating breakage of the holder.No adverse event involving a patient or user was reported.Diagnostic/functional testing was performed by remote service engineer (rse).Results of the evaluation confirmed the customer's alleged malfunction.The unit had the mounting holder broken which caused the whole monitor to be damaged; however, it was an itd holder which is a third-party market product.The philips device had no issue.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the breakage of the third -party itd holder.During the investigation it was clear that the third-party product itd holder was broken.Hence there was no issue with the philips device.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 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: 18895132
• MDR Text Key: 337560150
• Report Number: 9610816-2024-00145
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 Model Number: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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