MAUDE Adverse Event Report: AIR TECHNIQUES INC. AT2000 XR; PROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC

Model Number AT2000XR

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Shock (2072)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

A field service technician reported receiving an electrical shock from the at2000 xr device.The device is installed in a private dental office.

• Brand Name: AT2000 XR
• Type of Device: PROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC
• Manufacturer (Section D): AIR TECHNIQUES INC.; 1295 walt whitman road; melville NY 11747
• Manufacturer (Section G): AIR TECHNIQUES; 1295 walt whitman road; melville NY 11747
• Manufacturer Contact: griselda madrid ; 1295 walt whitman road; melville, NY 11747 ; 5162145541
• MDR Report Key: 6777948
• MDR Text Key: 82677348
• Report Number: 2428225-2017-00001
• Device Sequence Number: 1
• Product Code: IXW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/18/2017

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: No Information
• Device Model Number: AT2000XR
• Device Catalogue Number: 45000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/1999
• 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