DRX-EVOLUTION SYSTEM
Report
- Report Number
- 1317307-2023-00008
- Event Type
- Malfunction
- Date Received
- September 28, 2023
- Date of Event
- August 30, 2023
- Report Date
- November 22, 2023
- Manufacturer
- CARESTREAM HEALTH INC.
- Product Code
- KPR
- PMA / PMN Number
- K091889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ON (B)(6) 2023, AN INITIAL REPORT WAS SUBMITTED AS THERE WERE INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION. SUBMITTING FOLLOW UP #1 AS INVESTIGATION IS ONGOING. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.
ON 27-SEP-2023, AN INITIAL REPORT WAS SUBMITTED AS THERE WERE INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION. SUBMITTING FOLLOW UP #1 AS INVESTIGATION IS ONGOING. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS. UPDATE FOLLOW-UP #2 (FINAL): CARESTREAM HEALTH INC (CSH) HAS EVALUATED THE DRX-EVOLUTION SYSTEM. NO PATIENT INJURY OCCURRED. THE ROOT CAUSE IS CONFIRMED TO BE FAILURE OF WELDMENT DUE TO FATIGUE FRACTURES IN MATERIAL WELDS. THE SYSTEM IN QUESTION WAS IN USE FOR OVER 11 YEARS. THE CLAMP WELDMENT X-RAY TUBE WAS REPLACED AND THE SYSTEM IS UP AND RUNNING. IN ADDITION TO THAT, CARESTREAM HEALTH WILL ADD A VISUAL INSPECTION OF THE OTC ALPHA WELDMENT TO THE PREVENTIVE MAINTENANCE (PM) DOCUMENT FOR DRX-EVOLUTION SYSTEMS. FREQUENCY OF ONE YEAR IS SUFFICIENT TO VISUALLY NOTICE A CRACKED WELD BEFORE FATIGUE FAILURE. IT WAS CONFIRMED THAT THE TUBE DID NOT FALL TO THE FRONT AS ALLEGED ON THE ORIGINAL COMPLAINT, THE TUBE HEAD REMAINED ATTACHED TO THE GOOSENECK ASSEMBLY. THIS EVENT IS NOT CONSIDERED A SAFETY RISK AS THIS FAILURE MODE WOULD NOT CAUSE THE TUBE HEAD ASSEMBLY TO SEPARATE FROM THE SUPPORTING STRUCTURE IF IT WERE TO REOCCUR. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH RELATED TO THIS INCIDENT. CSH HAS CONCLUDED THIS INVESTIGATION.
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 28 DAYS HAS ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.
ON (B)(6)2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE THE ALPHA SHAFT OF THE DRX-EVOLUTION SYSTEM WAS CRACKED WHILE A RADIOGRAPHER WAS MANUALLY POSITIONING THE OTC (OVER HEAD TUBE CRANE) FOR A PATIENT ON A MOVABLE TABLE, AND THE USER ALLEGED THE TUBE FALL TO THE FRONT. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING. UDI: N/A. SYSTEM MANUFACTURED PRIOR TO UDI IMPLEMENTATION.
ON 30-AUG-2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE THE ALPHA SHAFT OF THE DRX-EVOLUTION SYSTEM WAS CRACKED WHILE A RADIOGRAPHER WAS MANUALLY POSITIONING THE OTC (OVER HEAD TUBE CRANE) FOR A PATIENT ON A MOVABLE TABLE, AND THE USER ALLEGED THE TUBE FALL TO THE FRONT. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.UDI: N/A. SYSTEM MANUFACTURED PRIOR TO UDI IMPLEMENTATION.
ON (B)(6) 2023, CARESTREAM HEALTH INC. WAS INFORMED OF AN INCIDENT WHERE THE ALPHA SHAFT OF THE DRX-EVOLUTION SYSTEM WAS CRACKED WHILE A RADIOGRAPHER WAS MANUALLY POSITIONING THE OTC (OVER HEAD TUBE CRANE) FOR A PATIENT ON A MOVABLE TABLE, AND THE USER ALLEGED THE TUBE FALL TO THE FRONT. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING. UDI: N/A. SYSTEM MANUFACTURED PRIOR TO UDI IMPLEMENTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003152 | DRX-EVOLUTION SYSTEM | DRX-EVOLUTION SYSTEM | KPR | CARESTREAM HEALTH INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |