MAUDE Adverse Event Report: AIR TECHNIQUES INC. AT2000XR; PROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC

Model Number AT2000XR

Device Problems Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)

Patient Problem No Information (3190)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device was requested many times from customer to be returned for evaluation but customer decided not to return it.Evaluation could not be performed.On (b)(6) 2018 report was previously submitted on time with successful ack3s responses but on (b)(6) 2018 we noticed that the mfr report # on the original report was incorrect.We have corrected the mfr report # (2428225-2018-00001.).

Event Description

Technician plugged in electrical connection between cover assembly and base unit before turning on the procecessor; he then heard the roller assemblies running and saw smoke at the round electrical connection.When he checked the electrical connection inside the unit he saw some wires with the insulation partially melted.

• Brand Name: AT2000XR
• 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 INC.; 1297 walt whitman road; melville NY 11747
• Manufacturer Contact: griselda madrid ; 1297 walt whitman road; melville, NY 11747 ; 5162145541
• MDR Report Key: 7555018
• MDR Text Key: 109758688
• Report Number: 2428225-2018-00001
• Device Sequence Number: 1
• Product Code: IXW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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