MAUDE Adverse Event Report: VILLA SISTEMI MEDICALI S.P.A. JUNO DRF; TABLE, RADIOLOGIC

Model Number 709020

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Head Injury (1879); Pain (1994)

Event Date 08/06/2015

Event Type  Injury  

Event Description

Philips was informed by a customer that the footboard of the device detached from the table top while a patient was positioned on the table.As a result the patient fell from the table and patient's head and back was injured.The patient was moved to er for examination and a muscle relaxant was prescribed.The patient was asked for a follow up visit after a few days.

• Brand Name: JUNO DRF
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): VILLA SISTEMI MEDICALI S.P.A.; via delle azalle 3,; 20090; buccinasco, ; IT
• MDR Report Key: 5080784
• MDR Text Key: 25946533
• Report Number: 1217116-2015-00002
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Radiologic Technologist
• Report Date: 08/11/2015,08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 709020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/06/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other