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

Model Number	PROXIDIAGNOST N90
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During annual physics testing, the stabilized dose is high during continuous fluoroscopy and pulsed fluoroscopy for 20 and 30 frames per second.
Additional 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
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• MDR Report Key: 11027848
• Report Number: 3003768251-2020-01003
• Device Sequence Number: 16457839
• Product Code: JAA
• UDI-Device Identifier: 00884838085619
• UDI-Public: 00884838085619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• 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
• Operator of Device: 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 Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0727-2021
• Patient Sequence Number: 1