NOMAD PRO2 0.850.0021 FP 0150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-18 for NOMAD PRO2 0.850.0021 FP 0150 manufactured by Airbex.

Event Text Entries

[139093173] The device was returned for repair on (b)(6) 2019, with an evaluation being performed on (b)(6) 2019, based on the initial complaint of system failure. This initial evaluation identified a potential thermal event. Upon further visual inspection it appears that a thermal event occurred. It is not possible to determine the exact sequence of events that led to the thermal event. However, there is evidence that a short occurred in the upper battery pack between the cells and printed circuit board. There was a blackening on the top of the upper battery pack and its printed circuit board. Cells 2 and 3 appear to have been involved in the thermal event, likely by supplying energy into a fault in the board. Additionally, there was a slight melting of the handset plastic enclosure. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10


[139093174] It was initially reported on (b)(6) 2019 that the device was giving a system failure message. There was no report of injuries, patient or user involvement, and no impact to patient care. The device was returned for repair and was received by the manufacturer on (b)(6) 2019. During an assessment by the repair department on (b)(6) 2019, a possible thermal event was identified on the handsets returned with the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017522-2019-00007
MDR Report Key8428530
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-03-18
Date of Report2019-03-14
Date of Event2019-01-16
Date Mfgr Received2019-01-16
Device Manufacturer Date2015-10-29
Date Added to Maude2019-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVID WATERS
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal28273
Manufacturer Phone7045877297
Manufacturer G1AIRBEX
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal Code28273
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOMAD PRO2
Generic NameEXTRAORAL SOURCE X-RAY SYSTEM
Product CodeEHD
Date Received2019-03-18
Returned To Mfg2019-02-20
Model Number0.850.0021
Catalog NumberFP 0150
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAIRBEX
Manufacturer Address11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-18

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