MAUDE Adverse Event Report: PALODEX GROUP OY GXDP-300; DIGITAL PANORAMIC X-RAY UNIT

Model Number	GXDP-300
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the volume of exposure warning speaker of a digital panoramic x-ray unit gxdp-300 (serial # (b)(4)) is too loud, and has allegedly contributed to an operator's claim of permanent ringing in ears.

• Brand Name: GXDP-300
• Common Device Name: DIGITAL PANORAMIC X-RAY UNIT
• Manufacturer (Section D): PALODEX GROUP OY; nahkelantie 160; tuusula, FI-00 430; FI FI-00430
• MDR Report Key: 6607953
• Report Number: 2530069-2017-00009
• Device Sequence Number: 18835441
• Product Code: MUH
• UDI-Device Identifier: 06430035872435
• UDI-Public: 06430035872435
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/05/2017
• Report Date (Section F): 06/02/2017

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
• Operator of Device: Dental Assistant
• Device Model Number: GXDP-300
• Device Catalogue Number: 900714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2017
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Date Report Sent to FDA: 06/02/2017