MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX600 PATIENT MONITOR

Model Number	865242
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a speaker malfunction.No adverse event involving a patient or user was reported.

• Brand Name: INTELLIVUE MX600 PATIENT MONITOR
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9130042
• Report Number: 9610816-2019-00255
• Device Sequence Number: 16283661
• Product Code: MHX
• UDI-Device Identifier: 00884838029095
• UDI-Public: (01)00884838029095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 865242
• Device Catalogue Number: 865242
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1