MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VM8: MICROSTREAM CO2; COMPACT PORTABLE PATIENT MONITORS

Model Number	863066
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported speaker error.The customer confirmed that the device was not connected to a patient when this event happened.

• Brand Name: VM8: MICROSTREAM CO2
• Common Device Name: COMPACT PORTABLE PATIENT MONITORS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8670198
• Report Number: 1218950-2019-03995
• Device Sequence Number: 16209090
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: (01)00884838000063
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 863066
• Device Catalogue Number: 863066
• 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: 05/22/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1