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

Model Number	866061
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported a speaker malfunction from the unit.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
H3 other text : material ordered only.
Event or Problem Description
After further investigation this was deemed not a reportable event with philips.The customer reported that a speaker malfunction inops was displayed from the device.The speaker created high and low volume intermittently the device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.A philips response service engineer (rse) spoke to the customer.A goods movement indicates parts were shipped to the customer to repair and resolve their issue.Replacement parts were ordered and shipped to the customer site.We will consider that the customer resolved the issue using the replacement parts ordered from philips.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15796088
• Report Number: 9610816-2022-00578
• Device Sequence Number: 19995843
• 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: Foreign,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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2019
• 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