MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VM1; PATIENT MONITOR

Model Number	863264
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 contacted the customer care solution center and reported that the complaint device was locked in the startup menu.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: VM1
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8897438
• Report Number: 1218950-2019-06119
• Device Sequence Number: 285856
• Product Code: MHX
• UDI-Device Identifier: 00884838028906
• UDI-Public: (01)00884838028906
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K082280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 863264
• Device Catalogue Number: 863264
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1