MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO; MONITOR, PHYSIOLOGICAL, PATIENT

Model Number FC 2010

Device Problems Failure to Read Input Signal (1581); Patient Data Problem (3197)

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

Event Date 12/29/2015

Event Type  malfunction  

Event Description

Failure occurred in the middle of the case requiring extensive troubleshooting and ultimately requiring the vital signs and aortic pressure (ao) to be transferred to the anesthesia machine.No patient harm.A few days later the ekg signal was not working requiring the use of the portable anesthesia machine.Monitor person had to manually chart the heart rate and rhythm in xper.No patient harm.Four days later, following the ekg signal not working, the non-invasive blood pressure (nibp) was still not working in this room and the staff was aware.Measures were taken to have the portable anesthesia machine available for nibp monitoring.Monitor person had to manually chart the nibp in xper.No patient harm.Manufacturer made aware and will send a replacement and this unit will be returned to them.

• Brand Name: XPER FLEX CARDIO
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 5412563
• MDR Text Key: 37540464
• Report Number: 5412563
• Device Sequence Number: 1
• Product Code: DRT
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/29/2015,01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FC 2010
• Device Catalogue Number: 453564243591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N.A.