Model Number 72200873 |
Device Problems
Smoking (1585); Moisture or Humidity Problem (2986)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that the dii controller had a short circuit failure, which resulted in smoke coming from the device.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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The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 concluded this was a repeat issue.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 at the time of manufacture in 2010, release from service in 2014, or release from service in 2015.A complaint history review concluded this was a repeat issue.A corrective action was previously initiated in august of 2017 to mitigate future recurrence of similar events.Following the completion of the root cause investigation, the capa included the incorporation of a design enhancement in august of 2018 to remove potential ground path(s) of components.A verification of effectiveness was successfully completed which demonstrated effectiveness of the design enhancement (including a determination that there were no confirmed instances of this failure mode occurring on units incorporating the enhanced design during the review period).As the subject device was manufactured/serviced prior to the implementation of the design enhancement, no further actions in relation to this event are deemed necessary at this time.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 concluded this was a repeat issue.
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Search Alerts/Recalls
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