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Catalog Number 7205971 |
Device Problem
Electrical Shorting (2926)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2018 |
Event Type
malfunction
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Event Description
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It was reported that the device was shorting out.There was a backup device available to complete the procedure with no delay.No patient injuries were reported.This is an obsolete product, therefore, the device cannot be exchanged, only returned.
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Manufacturer Narrative
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The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with hand piece overload when power cord was bent or twisted.Power cord assembly grew warm during testing.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.A visual inspection was performed on the power cords external covering and no physical damage was observed but insulation is discolored from overheating.It was determined that the power cord has shorted and/or opens internal wiring.Motor was tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.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.
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Search Alerts/Recalls
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