MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP2

Model Number	865040
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that there was a speaker malfunction.The device was not in use on a patient at the time of the event a field service engineer went on site and confirmed the reported problem of speaker malfunction.The speaker assembly was replaced to resolve the issue.The device was tested and was returned to full functionality.Follow up is needed to confirm if the malfunction was an error and if there was sound coming from the speaker.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Corrected data - the issue was previously reported against the mx800; however, additional information received indicates the issue was actually related to the mp2 module; therefore product information has been corrected.
Event or Problem Description
The customer reported the device displayed a speaker malfunction.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 field service engineer (fse) went onsite to evaluate the devices in question.The issue was initially reported on an mx800; however, the (fse) confirmed the issue was not the mx800, rather the mp2 module which was connected to the mx800.Results of functional testing confirm the mp2 module was completely out of sound; however, the mx800 monitor was able to produce a warning sound.There was a speaker malfunction inop coming through the mx800 which was connected to the mp2.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.The reported problem was confirmed.After speaker 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 MP2
• Common Device Name: INTELLIVUE MP2
• 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 ; 70314632031
• MDR Report Key: 16160227
• Report Number: 9610816-2023-00023
• Device Sequence Number: 19665104
• Product Code: MHX
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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: 865040
• Device Catalogue Number: 865040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2016
• 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