MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. KODAK DIRECTIEW 7500 SYSTEM; DR 7500

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/17/2014

Event Type  Injury  

Event Description

The patient was positioned on an x-ray table to lie on her left side.The radiology technologist (rt) moved the x-ray tabletop to position the patient for the exposure.While moving the tabletop, the tube and collimator assembly (beta assembly) disconnected from the overhead tube crane (otc) telescope and fell onto a patient causing injuries that required hospitalization.

Manufacturer Narrative

The investigation to understand root cause is in process.A follow-up report will be provided regarding the corrective and preventive action plan based upon root cause.

• Brand Name: KODAK DIRECTIEW 7500 SYSTEM
• Type of Device: DR 7500
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH, INC.; 1049 west ridge road; rochester NY 14615
• Manufacturer Contact: susan pate ; 150 verona street; rochester, NY 14608 ; 5856276557
• MDR Report Key: 4013950
• MDR Text Key: 4844929
• Report Number: 1317307-2014-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K051258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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): Required Intervention
• Patient Age: 76 YR