MAUDE Adverse Event Report: MIDMARK CORP PROGENCY JB-70; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number JB70

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

A dental assistant reported to a dealer field technician who then reported to midmark that a jb-70 x-ray unit, serial number (b)(4), generated exposure tone a couple of times when the tube head of the x-ray unit was moved into a position to take an x-ray image.The exposure tone is an audible signal to indicate that an x-ray image has been taken.

• Brand Name: PROGENCY JB-70
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow drive; linconlinshire IL 60089
• Manufacturer Contact: peng lin ; 675 heathrow drive; lincolnshire, IL 60065 ; 8474159787
• MDR Report Key: 4116929
• MDR Text Key: 4835976
• Report Number: 1423380-2014-00007
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JB70
• Device Catalogue Number: I7017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1