MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM1: SPO2, CO2, RECORDER; PATIENT MONITOR

Model Number	863266
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported a system hang/lockup.The customer confirmed that the device was not connected to a patient when this event happened.

• Brand Name: SURESIGNS VM1: SPO2, CO2, RECORDER
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8384953
• Report Number: 1218950-2019-01689
• Device Sequence Number: 1922208
• Product Code: MHX
• UDI-Device Identifier: 00884838009691
• UDI-Public: (01)00884838009691
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K082280
• 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,Followup
• Report Date (Section B): 02/16/2019

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: 863266
• Device Catalogue Number: 863266
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2019
• Supplement Date Received by Manufacturer: 02/16/2019
• Initial Report FDA Received Date: 03/03/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1