Model Number 5392 |
Device Problems
Corroded (1131); Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/13/2019 |
Event Type
malfunction
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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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Event Description
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It was reported that the rate knob of the external pulse generator (epg) appeared corroded, and it was stuck.It was suggested that the epg be returned for service.There was no patient involvement.
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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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Manufacturer Narrative
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Product analysis : analysis confirmed customer comment that pacing rate knob is stuck and corroded.Keypad and one knob are corroded.Lower case is broken.One case screw is contaminated.All found defective parts were replaced and all other identified issues were resolved.Passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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