MAUDE Adverse Event Report: PALODEX GROUP OY GENDEX; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number GXPS 500

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

This issue relates to the 7-8 years old defective power supply unit (psus) of gxps 500 scanners.Fda is aware of the field action and it is covered in recalls z-0839-2020 - z-0842-2020.This customer had received 3 notifications regarding the field action sent to the dental practice on (b)(6) 2020, on (b)(6) 2021 and on (b)(6) 2021 and had not yet ordered a replacement psu.Replacement unit received by customer.This concludes the investigation.

Event Description

Per (b)(6), dental office stated their gxps 500 power supply burned and it also melted the plastic on the port of the gxps 500 power unit.User indicates no patient involvement, no injury to personnel or property damage.

• Brand Name: GENDEX
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): PALODEX GROUP OY; 160 nahkelantie; tuusula, uusimaa 04300 ,FIN; FI 04300,FIN
• Manufacturer (Section G): PALODEX GROUP OY; 160 nahkelantie; tuusula, uusimaa 04300 , FI; FI 04300, FIN
• Manufacturer Contact: rainer harjunpää ; 160 nahkelantie; tuusula, uusimaa 04300-, FI ; FI 04300, FIN
• MDR Report Key: 15006088
• MDR Text Key: 303919501
• Report Number: 3005383085-2022-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GXPS 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0839-2020-Z-0842-2020
• Patient Sequence Number: 1