MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX430 PATIENT MONITOR

Model Number	866061
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the intellivue mx430 patient monitor unit was hung and there was no waveform.The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.A philips remote service engineer (rse) interviewed the customer to evaluate the device.The (rse) confirmed the alleged malfunction.After mainboard replacement, the device was returned to functional use with no further issues identified.The device remains at the customer site.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX430 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX430 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16186927
• Report Number: 9610816-2023-00028
• Device Sequence Number: 2429259
• Product Code: MWI
• UDI-Device Identifier: 00884838006379
• UDI-Public: 00884838006379
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: 866061
• Device Catalogue Number: 866061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown