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

Catalog Number 1739192

Device Problem Unintended Movement (3026)

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

Event Date 01/29/2024

Event Type  Injury  

Event Description

On 1-feb-2024, carestream health inc.Was informed of an unintended movement of the overhead tube crane (otc) while using the drx-evolution system.No injuries reported, the investigation is ongoing.

Manufacturer Narrative

Csh investigation is currently in progress.Submitting an initial report as there are insufficient facts available to make a reportability decision.Csh will submit a follow up with investigation update/findings within 30 days.

• Brand Name: CARESTREAM DRX EVOLUTION PLUS SYSTEM
• Type of Device: CARESTREAM DRX EVOLUTION PLUS SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 18728694
• MDR Text Key: 335714629
• Report Number: 1317307-2024-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K091889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1739192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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