MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90; SYSTEM, X-RAY, STATIONARY

Model Number PROXIDIAGNOST N90

Device Problem Radiation Output Problem (4026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Int.Ref.(b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

During annual physics testing, the stabilized dose is high during continuous fluoroscopy and pulsed fluoroscopy for 20 and 30 frames per second.

Manufacturer Narrative

Int.Ref.424305 the stationary nearby-controlled system supports general radiography and fluoroscopy imaging.The system has eleva workspot with eleva software integrated generator control, hand switch, keyboard, mouse, touch screen, and pc.There are various examination parameter settings available in eleva workspot.The investigation concluded that there was a software anomaly found in eleva software for dose calculation, which results in incorrect dose feedback causing the generator to regulate to (and stabilize at) a higher-than expected image dose.The issue started a capa investigation which led to a recall (fco 70600104).Philips field service engineer installed the fco.After this the risk is acceptable and the system is working as specified.The issue is further monitored and trended.Correction: h6 result and conclusion code.

• Brand Name: PROXIDIAGNOST N90
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• MDR Report Key: 11027848
• MDR Text Key: 222050247
• Report Number: 3003768251-2020-01003
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838085619
• UDI-Public: 00884838085619
• Combination Product (y/n): N
• PMA/PMN Number: K173433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROXIDIAGNOST N90
• Device Catalogue Number: 706100
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/18/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0727-2021
• Patient Sequence Number: 1