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Model Number 72200873 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that the dll controller was overheated.Incident occurred before the procedure; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with alarm sounding and "short circuit detected" error message on port a only.Cause of alarm and error is shorted and burned electronic components on the main digital pcb.Reason for electronic component failure is unknown but a shorted out mdu is a possibility.Product passed functional testing with a known good main pcb installed.The complaint investigation has concluded the cause of the failure to be defective electronic components on the main digital pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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