MAUDE Adverse Event Report: FYSICON B.V FYSICON QMAPP; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 01076010

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Protective Measures Problem (3015)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 05/18/2022

Event Type  Injury  

Event Description

During the start of a cath lab procedure the patient was connected to the fysicon qmapp system and as is normal, the system was displaying the patient's qrs, heart rate, pleth, and spo2 before the patient was admitted to the system.The staff attempted to start the procedure but were presented with a warning stating that the 'procedure process failed' and the case could not be started.The nursing staff continued to monitor the patient's vitals via this live hemo screen in the interim before the case could begin.It was then noticed on the system qmapp engine page that the 'data collector service' was stopped and the system gave them the option to 'start service' to resolve this issue.Upon clicking the 'start service' button the nibp value immediately displayed a blood pressure of 129/86(97) but this was not the patient's blood pressure value as the cuff had not yet inflated nor cycled through an acquisition process.This false blood pressure was noted by the monitor technician who informed the nursing staff to disregard this blood pressure value as they realized the system did not actually obtain this value from the patient, but instead displayed this fake value for some unknown reason.Further troubleshooting steps resolved the issue with starting the case and when the case was started the fictitious 129/86(97) blood pressure was zeroed out and the patient's actual blood pressure was then acquired which was displayed as 151/97(113).As indicated in the attached picture, the qrs and heart rate value of 60, and the pleth and spo2 value of 98 were the actual values from the patient being monitored.The nibp value of 129/86(97) however was not from the patient but was a fake value created by the fysicon qmapp system as described above.On another fysicon qmapp system it was confirmed that when the qmapp engine 'data collector service' stops for whatever reason which happens from time to time, and the 'start service' button is pressed on the qmapp engine page, the erroneous nibp value of 129/86(97) is displayed on the patient's live hemo screen and will remain there until a new recording case is started.Fda safety report id # (b)(4).

• Brand Name: FYSICON QMAPP
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): FYSICON B.V; oss, noord-brabant ; NL
• MDR Report Key: 14470569
• MDR Text Key: 292497558
• Report Number: MW5109816
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01076010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 99 KG