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

Model Number	866061
Medical Device Problem Code	Low Audible Alarm (1016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported there was a speaker malfunction error.The device was not in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Event or Problem Description
It was reported there was a speaker malfunction error.The device was not in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote support engineer (rse) provided the customer with replacement part information for the device loudspeaker assembly.The device remains at the customer site.
Additional Manufacturer Narrative
It was reported there was a speaker malfunction error.The device was not in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote support engineer (rse) provided the customer with replacement part information for the device loudspeaker assembly.The device remains at the customer site.

• 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 ; 222 jacobs street; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15971488
• Report Number: 9610816-2022-00628
• Device Sequence Number: 5668661
• 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: 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
• Operator of Device: Health Professional
• Device Model Number: 866061
• Device Catalogue Number: 866061
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/10/2023
• Date Device Manufactured: 02/17/2017
• 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