MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number PIIC IX VERSION B.02

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/27/2017

Event Type  malfunction  

Event Description

A patient's physiologic parameters were being monitored in intensive care with remote displays in two nurse's stations on separate central station monitors.One of the two central stations correctly presented the patient information while the other presented erroneous numerics and wave forms on the main screen.The only method that biomedical staff were able to find to correct the problem was to clear the sector on the affected central station and reassign it for the same patient.

• Brand Name: INTELLIVUE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6439147
• MDR Text Key: 71017791
• Report Number: 6439147
• Device Sequence Number: 1
• Product Code: MHX
• 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: Other
• Type of Report: Initial
• Report Date: 03/01/2017,03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PIIC IX VERSION B.02
• 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: 03/01/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2017
• 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