DRX REVOLUTION MOBILE X-RAY SYSTEM
Report
- Report Number
- 1317307-2023-00012
- Event Type
- Malfunction
- Date Received
- December 22, 2023
- Date of Event
- November 14, 2023
- Report Date
- March 6, 2024
- Manufacturer
- CARESTREAM HEALTH INC.
- Product Code
- IZL
- UDI-DI
- 60889978618897
- PMA / PMN Number
- K191025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE INVESTIGATION LOGS COULD NOT BE OBTAINED FROM THE IMPACTED SYSTEM. FROM THE LIMITED INFORMATION AVAILABLE, THE INVESTIGATION TEAM DETERMINED THAT CONNECTORS ON THE CHARGER MONITOR BOARD (CMB) WERE NOT FULLY SEATED AND LATCHED THAT LED TO ARCING BETWEEN CONTACTS. THIS MAY PRODUCE EXCESSIVE HEAT LEADING TO THE THERMAL INCIDENT OBSERVED. CARESTREAM HAS REPAIRED THE CUSTOMER'S SYSTEM AND INITIATED A CORRECTIVE ACTION TO REVIEW AND UPDATE APPLICABLE SERVICING AND MANUFACTURING PROCEDURES TO ENSURE CONNECTORS ARE FULLY SEATED. PER THE PRODUCT SAFETY & PERFORMANCE RISK ASSESSMENT, CARESTREAM'S INVESTIGATION TEAM DETERMINED THAT THE OVERALL PRODUCT SAFETY RISK IS LOW. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. THERE ARE NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS TO BE TAKEN BY CARESTREAM HEALTH INC. RELATED TO THIS ISSUE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.
ON DECEMBER 13, 2023 AN INITIAL REPORT WAS SUBMITTED AS THERE WERE INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION. SUBMITTING A FOLLOW UP #1 AS INVESTIGATION IS ONGOING. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.
ON DECEMBER 13, 2023 AN INITIAL REPORT WAS SUBMITTED AS THERE WERE INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION. SUBMITTING A FOLLOW UP #2 AS INVESTIGATION IS ONGOING. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.
CSH INVESTIGATION IS CURRENTLY IN PROGRESS. SUBMITTING AN INITIAL REPORT AS THERE ARE CURRENTLY INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION AND AT LEAST 29 DAYS HAS ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.
ON 14-NOV-2023, CARESTREAM HEALTH INC. WAS INFORMED OF A THERMAL INCIDENT RELATED TO THE DRX-REVOLUTION SYSTEM. NO INJURIES REPORTED.
ON 14-NOV-2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE SMOKE WAS COMING OUT OF THE DRX-REVOLUTION SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.
ON 14-NOV-2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE SMOKE WAS COMING OUT OF THE DRX-REVOLUTION SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.
ON 14-NOV-2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE SMOKE WAS COMING OUT OF THE DRX-REVOLUTION SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2168937 | DRX REVOLUTION MOBILE X-RAY SYSTEM | DRX REVOLUTION MOBILE X-RAY SYSTEM | IZL | CARESTREAM HEALTH INC. | 60889978618897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |