MAUDE Adverse Event Report: MIDMARK CORPORATION JB-70 INTRAORAL DENTAL X-RAY SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number JB-70

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a servicing technician reported that a jb-70 intraoral dental x-ray system (serial no.(b)(4)) unexpectedly generated an exposure tone when it was powered on.The exposure tone is an audible signal that indicates that an x-ray image has been taken.There was no report of injury or patient involvement.The unit has since been replaced with a newer model.

• Brand Name: JB-70 INTRAORAL DENTAL X-RAY SYSTEM
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow dr.; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 8474159739
• MDR Report Key: 5010852
• MDR Text Key: 24781583
• Report Number: 1423380-2015-00020
• 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: Service Personnel
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 07/20/2015

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: Service Personnel
• Device Model Number: JB-70
• Device Catalogue Number: I7016-PG
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1