Date of event: (b)(6).Date of report: 26aug2019.The manufacturer's technical services (ts) found a defect in the pcb interface board, "battery charger fault" error.A quote was provided to the customer for the replacement of parts however, numerous attempts to follow up with the customer on the repair status of the unit and resolution to the problem proved unsuccessful.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
|