Model Number 6382 |
Device Problem
Cut In Material (2454)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per fsr, the user facility had electrical tape covering the cut cable.He replaced the flow sensor.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the cable had a cut through the insulation exposing the wires.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the cables insulation to be cut exposing the internal wires.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This complaint is related to (b)(4) / medwatch #1828100-2018-00138.
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Search Alerts/Recalls
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