Model Number 5392 |
Device Problems
Nonstandard Device (1420); Calibration Problem (2890); Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that the external pulse generator had a missing knob and a broken knob connector.The generator was returned for service.There was no patient involvement.
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Manufacturer Narrative
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Product event summary: analysis was able to confirm the customer comment of a missing knob and broken knob connector, the upper case was broken and one knob missing.Analysis further noted that the hanger assembly, hanger screw and one case screw were contaminated, the keyboard was scratched and the encoder switch assembly had a piece of the upper case stuck.All found defective parts were replaced and all other identified issues were resolved.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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