MAUDE Adverse Event Report: CARESTREAM HEALTH INC DRX EVOLUTION SYSTEM

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Carestream health has opened a capa and is investigating this incident.A follow up mdr will be submitted when information is available.

Event Description

Carestream health received a complaint from the user site alleging that the evolution otc moved unintentionally.There were no injuries associated with this incident.

Manufacturer Narrative

Field service reported that the emergency stop switches were functioning correctly.Emergency stop switches are located on the wall stand, otc, and operator console.There are two emergency stop switches on the table.Field service could not duplicate the reported event at the site.System log files were returned to the factory for investigation.The investigation team also examined and tested the returned keypad.The keypad showed no cause for malfunction.The investigation found no defect and no further action is required.

Event Description

Carestream health received a complaint from the user site alleging that the evolution otc moved unintentionally.There were no injuries associated with this incident.

• Brand Name: DRX EVOLUTION SYSTEM
• Type of Device: DRX EVOLUTION SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC; 1049 ridge rd west; rochester NY 14615
• Manufacturer Contact: michael callery ; 150 verona st; rochester, NY 14608
• MDR Report Key: 6461423
• MDR Text Key: 71840597
• Report Number: 1317307-2017-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other