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

Catalog Number 8624181

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 309197363
• Report Number: 3004105475-2023-00001
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 60889978624188
• UDI-Public: 0160889978624188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8624181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other