FDA Adverse Event Malfunction Summary report: N

XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM

MDR report key: 3758547 · Received April 15, 2014

Report

Report Number
3758547
Event Type
Malfunction
Date Received
April 15, 2014
Date of Event
February 19, 2014
Report Date
April 15, 2014
Manufacturer
WITT BIOMEDICAL CORPORATION
Product Code
DQK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

PHILLIPS WITT HEMODYNAMIC MONITORING SYSTEM WOULD NOT RECORD HEMODYNAMICS. HAD TO REBOOT SYSTEM. CALL MADE TO WITT. ATTENDING REQUESTED SAFETY REPORT BE PLACED. CAUSED DELAY IN PROCEDURE.ONGOING AND UNRESOLVED ISSUES WITH SYSTEM. ADDITIONAL MEDSUN REPORTS TO FOLLOW. REBOOT OF SYSTEM AND TROUBLESHOOTING ARE OCCURRING WHILE PATIENT IS SEDATED AND ON TABLE. MANUFACTURER IS AWARE. SOME OF THE REPORTED ISSUES BY STAFF USING SYSTEM ARE AS FOLLOWS:PREVIOUS PATIENT INFORMATION CAN SHOW UP ON NEXT CASE IF THERE IS NO ACTIVE RECORDING.WHILE DOING CARDIAC OUTPUT, SOMETIME CAN'T SEE THE CURVE, ONLY THE NUMERIC VALUE. SOME OF THE WAVEFORMS WERE DELETED WHILE PERFORMING CARDIAC OUTPUTS.CAL VALUES ARE NOT BE DISPLAYED.HEMOGLOBIN VALUES FALLING OFF.INACCURATE RECORDINGS.CAN'T FIND RECORDED DATA.CANNOT FILTER THROUGH THE SEARCH FEATURE.INJECTION VALUES - IF NOT ALL VALUES ARE ENTERED, RESULTS IN DATA LOSS.VO2 IS INCORRECTLY DISPLAYED.ADDITIONALLY THE FOLLOWING ARE SOME OF THE PROBLEM DESCRIPTIONS LOGGED OVER TIME WITH SOME REFERENCING CALLS PLACED WITH THE MANUFACTURER:WILL NOT SELECT WAVEFORM TRACINGS AND WILL NOT LABEL POINTS ON TRACINGS IN WAVE REVIEW.WILL NOT DELETE LINE ITEMS OR RE-CHART. REBOOT X 2.PULLBACK NO RECORDING.SATS ON HEMO PAGE CHANGED.NOT ABLE TO LABEL ORIGINAL RECORDING/DROPPING INFO/FREEZING UP.BLUE SCREEN!! REBOOTED.WITT NOT SHOWING PRESSURE.SEQUENCE PULLBACK NOT WORKING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
229424 XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK WITT BIOMEDICAL CORPORATION HOST PC N/A

Patients

Seq Age Sex Outcome Treatment
1 5 MO