(b)(4).The device was evaluated by the in-country distributor and has been returned to the mfr and not yet received at this time.According to the distributor, "pt circuit calibration test passed.Measure the power supply +15, -15v is normal.Measure the voltage across 9800uf capacitor is normal.Measure the resistance of the coil within the driver is normal.The indicator on driver controller module is red.Replaced the driver controller module the ventilator is o.K.".Carefusion issued a return goods authorization (rga) number for the return of the alleged driver power module assembly 3100a, part number 24-768930 on 11/24/2014.As of 12/23/2014 the alleged part number has not been received.Should the part be received and evaluated, a follow-up medwatch report will be submitted.
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