AT2000XR 45000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for AT2000XR 45000 manufactured by Air Techniques Inc..

Event Text Entries

[109758688] 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. )
Patient Sequence No: 1, Text Type: N, H10


[109758689] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2428225-2018-00001
MDR Report Key7555018
Date Received2018-05-30
Date of Report2018-02-05
Date of Event2018-02-05
Date Mfgr Received2018-05-02
Device Manufacturer Date2011-08-31
Date Added to Maude2018-05-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. GRISELDA MADRID
Manufacturer Street1297 WALT WHITMAN ROAD
Manufacturer CityMELVILLE NY 11747
Manufacturer CountryUS
Manufacturer Postal11747
Manufacturer Phone5162145541
Manufacturer G1AIR TECHNIQUES INC.
Manufacturer Street1297 WALT WHITMAN ROAD
Manufacturer CityMELVILLE NY 11747
Manufacturer CountryUS
Manufacturer Postal Code11747
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAT2000XR
Generic NamePROCESSOR, RADIOGRAPHIC, FILM AUTOMATIC
Product CodeIXW
Date Received2018-05-30
Model NumberAT2000XR
Catalog Number45000
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAIR TECHNIQUES INC.
Manufacturer Address1295 WALT WHITMAN ROAD MELVILLE NY 11747 US 11747


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-30

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