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 11/20/2023

Event Type  malfunction  

Event Description

It was reported that the entire front display is defective due to fall damage.It is unknown if the device fell from a mount or if it was dropped.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.The device was returned for bench repair.The repair completion is pending receipt of a part.

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.E1 reporting address state: (b)(6).E1 reporting institution phone#: (b)(6).

Manufacturer Narrative

Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that the touch bezel and the lcd display were damaged and must be replaced.The bench repair technician (brt) replaced parts (453564406311- iv2-flex dspl lcd assembly 12 and 453564406281-iv2-flex touch bezel assembly) to resolve the issue.A good faith effort (gfe) conducted to obtain data regarding the fall damaged device.The brt indicates that the issues was caused by the user.

• 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: 18305026
• MDR Text Key: 330429440
• Report Number: 9610816-2023-00652
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 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 Operator: Health Professional
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/01/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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