MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number	865241
Medical Device Problem Codes	No Audible Alarm (1019); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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 a speaker malfunction on the intellivue mx700 patient monitor.It is unknown if sound was still coming from the device.The device was not in use monitoring a patient at the time of the reported issue.No adverse patient or user event was reported.
Event or Problem Description
The customer reported that a "speaker malfunction" inop was displayed on the intellivue mx700 patient monitor and no sound was coming from the device.The device was not in use monitoring a patient at the time of the reported issue.No adverse patient or user event was reported.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue mx700 patient monitor indicating that there was a speaker malfunction error.A good faith effort (gfe) was performed to clarify if the speaker produced sound, and it was provided that there was no sound.A remote service engineer (rse) determined that the speaker required replacement.Based on the information available and the testing conducted, the cause of the reported problem was the speaker.The reported problem was confirmed.The customer was provided a replacement speaker to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.The device remains at the customer site.
Additional Manufacturer Narrative
D4: product udi - the manufacturing date for the reported device is prior to 24sept2016.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX700 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 ; 70314632031
• MDR Report Key: 18235789
• Report Number: 9610816-2023-00636
• Device Sequence Number: 7152417
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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: 865241
• Device Catalogue Number: 865241
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 07/08/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/22/2023; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2013
• 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