MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX100

Model Number	867033
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips remote service engineer (rse) spoke to the customer and confirmed a ¿speaker problem¿ the device was confirmed to functioning in standalone mode, completely out of sound and displaying an inop message without sound.The rse determined that the "speaker assembly" needed to be replaced.A nemo (non engineering material only) service was agreed upon.The customer ordered a replacement of speaker to resolve the issue.Results of functional testing indicate a malfunction of the device.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.E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).
Event or Problem Description
It was reported that the intellivue patient monitor mx10 had a "speaker cable is damaged." it is unknown if the device was in clinical use at the time of the event.No adverse event occurred.

• Brand Name: INTELLIVUE MX100
• Common Device Name: INTELLIVUE MX100
• 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: 18388564
• Report Number: 9610816-2023-00685
• Device Sequence Number: 2772869
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: 00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K171801
• 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

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: 867033
• Device Catalogue Number: 867033
• 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: 11/30/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown