MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DCM GMBH EASYDIAGNOST ELEVA

Model Number 706050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Tissue Damage (2104); Physical Entrapment (2327)

Event Date 09/25/2014

Event Type  Injury  

Event Description

Philips received a report from a customer that pt's finger got caught in the lead apron track.The lead apron is designed to prevent the operator from scattered radiation.It is inserted in a track underneath the scopomat.The lead apron was removed by the customer, because the doctor doesn't like to work with the apron while performing examinations with the table in upright position.During the exam process the pt's finger became lodged in the radiation protection apron rail.Since the pt was unable to communicate pain, his/her condition was not noticed until there was significant bleeding coming from his/her finger.The finger skin tissue was cut and 3 stitches were needed as treatment.

Manufacturer Narrative

This event occurred since the operator did not properly secure the pt at the scopomat.The customer admitted that this is an accident, and the equipment was not the direct cause of the problem.No further actions are required.(b)(4).

• Brand Name: EASYDIAGNOST ELEVA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DCM GMBH; roentgenstrasse 24; hamburg 2233 5; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DCM GMBH; roentgenstrasse 24; hamburg 2233 5; GM 22335
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4203317
• MDR Text Key: 4980617
• Report Number: 3003768251-2014-00015
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

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
• Device Model Number: 706050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 6 YR