MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS CENTRAL MONITOR; SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Model Number HP F7M34UC #ABA

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Date 10/01/2016

Event Type  malfunction  

Event Description

The philips central telemetry monitoring platform malfunctioned twice overnight.Around 23:30-midnight, all pt "boxes" froze their values and turned blue and the screen froze.Bedside monitors working normally.Central monitor would not come back online, so we were forced to reset.Around 5:45 in the morning, an rn was at the screen looking at strips, when the screens froze again, a screen that said "philips" popped up, the computers restarted and reset on its own.Again, bedside monitors did function normally.Central monitor came back online and is functioning properly.

• Brand Name: PHILIPS CENTRAL MONITOR
• Type of Device: SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6310495
• MDR Text Key: 66806947
• Report Number: 6310495
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HP F7M34UC #ABA
• Device Lot Number: 453564468921
• Other Device ID Number: NPH 08249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1