MAUDE Adverse Event Report: CARESTREAM HEALTH INC CS 2200 INTRAORAL X-RAY SYSTEM

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2014

Event Type  malfunction  

Manufacturer Narrative

This mdr is retrospectively being submitted after an evaluation of an event that occurred on (b)(6) 2014 which resulted in a patient injury.The defect that is associated with this event(s) was determined reportable as a class ii recall under z-1127-2014.

Event Description

On (b)(6) 2014, we were told of a (b)(4) 2200 arm falling incident in (b)(6), we sent someone to investigate, there were no injuries associated with this event.

• Brand Name: CS 2200 INTRAORAL X-RAY SYSTEM
• Type of Device: CS 2200
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH FRANCE; 1 rue gallilee; noisy-le-grand, 93192 -FR; FR 93192-FR
• Manufacturer Contact: lee millward ; 150 verona street; rochester 14608 ; 1614399607
• MDR Report Key: 6458676
• MDR Text Key: 71700734
• Report Number: 8020825-2017-00007
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K060292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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