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

Model Number	867033
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the mx100 monitor shows a speaker malfunction error message.No sound was present.Patient involvement is unknown.There was no report of patient or user harm.
Additional Manufacturer Narrative
Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the mx100 monitor shows a speaker malfunction error message.No sound was present.Patient involvement is unknown.There was no report of patient or user harm.The product associated with the event was returned and evaluation/analysis was performed.The engineer determined that the issue was associated with the connection of the speaker to the main board.The speaker cable was reconnected to resolve the issue, and the device was returned to functional use.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15760612
• Report Number: 9610816-2022-00569
• Device Sequence Number: 8221526
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: 00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,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: 867033
• Device Catalogue Number: 867033
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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