MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX-COMPASS X-RAY SYSTEM

Catalog Number	8624181
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 06-jan-2023, carestream health was informed by a dealer of a customer issue "when trying to push otc z axis motor down button, after releasing the button, otc continued to move down on its own.Tech pressed the "all brake release" button to stop the movement.The issue was intermittent." there was no injury to the patient or the tech/operator.
Additional Manufacturer Narrative
A situation occurred where a site technician pressed the overhead tube crane (otc) motor down button, after releasing the button, the otc continued to move, towards the table requiring the user to push the all breaks release button.No patient injury occurred.Carestream will implement a field correction to address the potentially impacted systems at customer sites.

• Brand Name: DRX-COMPASS X-RAY SYSTEM
• Common Device Name: DRX-COMPASS X-RAY SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; building7 no 1510 chuanqiao rd; china pilot free trade zone; shanghai, shanghai, china 20120 6; CH 201206
• Manufacturer Contact: nancy mejias ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 16271767
• Report Number: 3004105475-2023-00001
• Device Sequence Number: 20341938
• Product Code: KPR
• UDI-Device Identifier: 60889978624188
• UDI-Public: 0160889978624188
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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 Catalogue Number: 8624181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown