FDA Adverse Event Injury Summary report: N

DRX REVOLUTION MOBILE X-RAY SYSTEM

MDR report key: 21249360 · Received January 27, 2025

Report

Report Number: 1317307-2025-00001
Event Type: Injury
Date Received: January 27, 2025
Date of Event: December 31, 2024
Report Date: January 13, 2025
Manufacturer: CARESTREAM HEALTH INC.
Product Code: IZL
PMA / PMN Number: K191025
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND IT WAS DETERMINED THAT THIS WAS DUE TO USER ERROR WHILE DRIVING THE UNIT AS THE TECH KNEELED ON ONE KNEE BEHIND THE DRX-REVOLUTION AND REVERSED THE UNIT WITH ONE HAND ON THE DRIVE HANDLE. THIS RESULTED IN THE TECH'S TOE TO BE FRACTURED. CARESTREAM HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS REGARDING THE MEDICAL ATTENTION REQUIRED; HOWEVER, IT WAS CONFIRMED THAT A WALKING BOOT IS BEING USED BY THE TECH. THE CUSTOMER SITE WAS INFORMED OF THE FINDINGS AND CSH REITERATED TO FOLLOW THE INSTRUCTIONS FOR USE AND RECOMMENDED GUIDELINES FOR DRIVING THE SYSTEM. THE DRX-REVOLUTION SYSTEM WAS EVALUATED, AND IT WAS CONFIRMED THAT IT WAS FUNCTIONING AS DESIGNED AND INTENDED. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH INC. RELATED TO THIS ISSUE. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

Description of Event or Problem · 0

ON 31-DEC-2024, CARESTREAM HEALTH INC. (CSH) WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION MOBILE X-RAY SYSTEM. THERE IS NO UDI NUMBER AVAILABLE AS THIS SYSTEM WAS MANUFACTURED ON APRIL 2013, PRIOR TO UDI IMPLEMENTATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2376570	DRX REVOLUTION MOBILE X-RAY SYSTEM	DRX REVOLUTION MOBILE X-RAY SYSTEM	IZL	CARESTREAM HEALTH INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other