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

Model Number	865241
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported speaker malfunction inop.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue mx700 patient monitor indicating that there was a speaker malfunction.A good faith effort (gfe) was performed to clarify if the customer was alleging sound issues with the speaker or only a speaker malfunction inop on the monitor, but no additional information was provided.The device was sent to philips bench repair.A philips bench repair technician (brt) evaluated the device and was unable to confirm the issue.No speaker malfunction error was appearing on screen.The brt confirmed that sound was emitting from the device properly at different volumes.There was no trouble with the device during testing.Based on the information available and the testing conducted philips was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The brt replaced the speaker for preventative measure.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported a speaker malfunction inop.It is unknown if sound was still coming from the device.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
D4 data correction to device identifier product udi.

• 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: 18418422
• Report Number: 9610816-2023-00692
• Device Sequence Number: 7846741
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088(21)DE58555679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 07/08/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/22/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2018
• 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