MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR

Model Number	M3001A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the spo2 parameter is intermittently operating on their intellivue measurement server (mms) device.No adverse event involving patient or user was reported.

• Brand Name: INTELLIVUE MUTLI MEASUREMENT SERVER (MMS)
• Common Device Name: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9888601
• Report Number: 9610816-2020-00107
• Device Sequence Number: 13644754
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: (01)00884838000254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: M3001A
• Device Catalogue Number: 862442
• 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: 03/02/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1