FDA Adverse Event Injury Summary report: N

COMBI DIAGNOST R90

MDR report key: 17005209 · Received May 24, 2023

Report

Report Number
MW5117876
Event Type
Injury
Date Received
May 24, 2023
Date of Event
May 23, 2023
Report Date
May 23, 2023
Manufacturer
PHILIPS MEDICAL SYSTEMS DMC GMBH
Product Code
JAA
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
BIOMEDICAL ENGINEER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT WAS PLACED ON TABLE FOR AN ARTHROGRAM. BEFORE THE INJECTION, THE FLUORO MONITOR IN THE ROOM WENT BLACK. THE FLUORO MONITOR IN THE CONTROL AREA STILL WORKED, HOWEVER A RE-BOOT OF THE SYSTEM DID NOT RESOLVE THE ISSUE. PATIENT WAS MOVED TO A DIFFERENT ROOM AND PROCEDURE WAS COMPLETED. NO HARM TO THE PATIENT EXCEPT DELAY IN CASE. ROOM HAD A FCO COMPLETED ON IT THE DAY BEFORE - (B)(4) UNDER PHILIPS WO (B)(4). ROOM WAS TESTED AFTER THE FCO WAS COMPLETED AND AGAIN THE MORNING OF THE CASE, BUT WHEN THIS FIRST CASE WAS STARTED, SYSTEM FAILED. UNSURE IF THIS IS RELATED TO THE FCO OR THE WORK DONE BY PHILIPS TECHNICIAN (B)(4). PHILIPS WAS CALLED BACK IN TO REVIEW AND RESOLVE. PHILIPS CALIBRATED THE MONITOR. ADJUSTED EXAM ROOM MONITOR VGA TO HDMI THEN ALL MONITORS ARE FUNCTIONAL. TESTED THE SYSTEM RETURNED TO CLINICAL USE. PHILIPS REPRESENTATIVE (B)(4) INDICATED HE WOULD FOLLOW UP WITH NSS (B)(4) TO SEE IF THIS CALIBRATION OF THE EXAM ROOM MONITOR THAT MUZAPAER COMPLETED THIS MORNING AFTER THE ROOM WAS IN USE, SHOULD HAVE BEEN DONE DURING THE FCO. ACCORDING TO (B)(4), EITHER THE FCO PROCEDURE IS LACKING OR (B)(4) MISSED STEPS. EITHER SITUATION IS NOT ACCEPTABLE AND PHILIPS NEEDS TO PREVENT THIS FOR FUTURE FCO'S/REPAIRS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
666958 COMBI DIAGNOST R90 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA PHILIPS MEDICAL SYSTEMS DMC GMBH 709031

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention