MAUDE Adverse Event Report: SUMMIT INDUSTRIES SUMMIT COLLIMATOR; D800 COLLIMATOR

Model Number D800

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Facility informed us (service provider) that the collimator came loose and fell striking a pt in the leg while on the x-ray table.We repaired collimator for further use.Condition of pt is unk.We (service provider), were called in to come fix the issue when we were told about the collimator striking a pt.We were not the current service provider of the medical x-ray equipment.Our service engineer remembered the recall from 2007 and repaired according to the recall instructions.Original recall dated 8/3/2007.This report provided by: (b)(6).(b)(4).

• Brand Name: SUMMIT COLLIMATOR
• Type of Device: D800 COLLIMATOR
• Manufacturer (Section D): SUMMIT INDUSTRIES; 2901 w lawrence ave; chicago IL 60625
• MDR Report Key: 3929691
• MDR Text Key: 4598580
• Report Number: 3929691
• Device Sequence Number: 1
• Product Code: KPW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D800
• Device Catalogue Number: MATCH 200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/05/2014
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other