MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. CARESTEAM DRX-EVOLUTION

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 09/26/2014

Event Type  Injury  

Event Description

Customer reports that the equipment froze and the radiology technologist (rt) could not continue with x-ray imaging.The rt powered down the equipment and when turning the power back on, the overhead tube crane (otc) lowered and contacted the patient's ankle area.It is questionable as to whether this caused injury to the patient.

Manufacturer Narrative

The equipment was evaluated by the field engineer at the customer site.It was noted that the issue occurred when powering the equipment down rather than on power-up based upon testing.The root cause of the issue was that the otc counterbalance was out of adjustment.This adjustment is part of the preventative maintenance (pm) completed on the equipment every 6 months.It was noted that the pm adjustment had not been completed during the recommended timeframes.The counterbalance was adjusted and verified to perform according to specifications.

• Brand Name: CARESTEAM DRX-EVOLUTION
• Type of Device: DRX-EVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; rochester NY 14608
• Manufacturer Contact: susan pate, rac ; 150 verona st.; rochester, NY 14608 ; 5856276557
• MDR Report Key: 4196065
• MDR Text Key: 5146789
• Report Number: 1317307-2014-00018
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091889
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/21/2014

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: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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