MAUDE Adverse Event Report: CARESTREAM HEALTH INC CARESTREAM DRX EVOLUTION SYSTEM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Carestream health is investigating this incident and will provide an update as soon as more information is available.

Event Description

Customer alleged that three screws attaching the otc weldment to the alpha brake were loose.There was no associated injury.

Manufacturer Narrative

Since the initial mdr was submitted, additional information was gathered from this site.It was discovered that screws were only loose by approximately one-half turn each.Carestream conducted a mechanical safety assessment and concluded that if two screws were completely removed and only one screw was remaining and engaged by 1 mm, the overhead tube crane (otc) would remain attached to the units and would not fall.The device associated with the initial mdr had all three screws loose by approximately one-half turn, therefore, this did not introduce a hazard.The capa investigation concluded that since the inception of the drx evolution product, carestream has never received a complaint or service call pertaining to the otc falling off or disengaging from the system.Since 2011, with over 2100 evolution systems in the field, analysis shows that in terms of defects per million opportunities, a problem with otc movement linked to loose screws may occur once in approximately 4.5 million opportunities in the field, indicating the chance of occurrence for the defect mode is improbable.The root cause analysis could not determine a definitive root cause as to why these screws were loose.The most probable root cause based on the investigation is the system experienced an excessive external force to the otc assembly which un-torqued the screws and allowed them to loosen.It has been determined that no field action is required to the installed base as a result of this incident and the investigation is now complete.This concludes the follow up/final report.Additional correction: the initial mdr report date is incorrect.The date initial mdr was submitted was april 17 2018 not march 16 2018.

Event Description

Customer alleged that three screws attaching the otc weldment to the alpha brake were loose.There was no associated injury.

• Brand Name: CARESTREAM DRX EVOLUTION SYSTEM
• Type of Device: DRX EVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• MDR Report Key: 7438360
• MDR Text Key: 105780459
• Report Number: 1317307-2018-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: 091889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other