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

Model Number 0.805.9510

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

A dealer technician was on site 11/7/2022 at the doctor's office and checked the unit for visual evidence of a possible electrical short (scorch marks), and for any exposed wires on the unit.There were no evidence of an electrical short, nor any exposed wires found.The dealer technician took multiple exposures, whereby no errors or malfunction occurred.On 11/17/2022 a dental imaging technologies corporation (ditc) technician (initial importer) visited the doctor's office to take photos of the device and perform additional testing.The incoming voltage to the unit was constant.In review of the photos, two exposed wires were observed.Tube head ground wire.Scissor arm cable where it meets the horizontal arm.The technician did not see any other cable damage inside the scissor or horizontal arm, or on the generator board.The staff member who reported being shocked was not in the office during this visit, thus the actual location of where the reported spark occurred could not be confirmed.The unit was being used at time of this visit and the ditc technician advised the manager to discontinue use of the unit, and applied appropriate signage on the unit.The unit will be returned to the manufacturer for further investigation, whereby a follow-up report will be submitted when the investigation is completed.

Event Description

It was reported by a dental office that a staff member received a shock from the unit while preparing for clinical use.Staff reported seeing a white spark/ flash from the back of the horizontal arm where it meets the wall.No injuries or medical attention was reported.

Manufacturer Narrative

The unit investigation was completed on 1/13/2023.A broken tubehead protective earthing cable was discovered, whereby two (2) strands were broken.There is no evidence of the cause of the broken strands.The electrical safety test was run for the device in production.All test cases were passed except the tubehead arm earth resistance test due to broken pe wire.Even with broken wire, the tubehead arm earth resistance was still only 101mohm, while the highest allowed value in production is 90mohm.The safety standard 60601-1 allows 100mohm resistance.All other cables, cable joints and connectors were in good condition, with no signs of corrosion, sparking or burn anywhere on the device.The reported problem i.E.Electric shock was not repeatable and no reason was found that could have caused the electric shock.Based on the investigations the product has stayed safe despite the broken pe wire.This concludes the investigation.

• Brand Name: FOCUS
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): PALODEX GROUP OY; nahkelantie 160; tuusula, uusimaa 04300 ; FI 04300
• Manufacturer (Section G): PALODEX GROUP OY; nahkelantie 160; tuusula, uusimaa 04300 ; FI 04300
• Manufacturer Contact: rainer harjunpaa ; nahkelantie 160; tuusula, uusimaa 04300 ; FI 04300
• MDR Report Key: 15907048
• MDR Text Key: 308067537
• Report Number: 3005383085-2022-00003
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 06430035872695
• UDI-Public: (01)06430035872695
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.805.9510
• Device Catalogue Number: 900986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1