MAUDE Adverse Event Report: PHILIPS FLEXVISION; MONITOR

Model Number 722012

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2015

Event Type  malfunction  

Event Description

Philips flexvision video display assembly fell to the floor.No patients or employees were injured.Initial report from philips indicates actuator assembly malfunction, awaiting final report.

• Brand Name: FLEXVISION
• Type of Device: MONITOR
• Manufacturer (Section D): PHILIPS; maumee OH 43537
• MDR Report Key: 4569824
• MDR Text Key: 5476501
• Report Number: MW5041085
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2015

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
• Device Operator: Health Professional
• Device Model Number: 722012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1