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Lot Number US815F1283 |
Device Problems
Fire (1245); Device Emits Odor (1425); Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the power module will be included in a follow up report upon its return and investigation completion.
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Event Description
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A customer reported their affiniti ultrasound system had produced a burning odor and a small flame from the back of the unit.No patient or user was harmed as a result of the issue.The site¿s local service engineer inspected the system and determined the problem was caused by a failed power module.After replacing the power module and power cord, the system passed all tests and was returned to service.
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Manufacturer Narrative
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The suspect power module was returned to the supplier, delta, to further investigate the reported failure.Delta confirmed the problem as described by the customer.A detailed failure analysis was performed and concluded the issue was caused by a burnt diode triggered by mechanical stress.Delta is aware of this issue with this specific diode model and has stopped including this part in the production of newer power modules.A supplier corrective action report (scar #us¿ (b)(4)) was initiated for this issue.
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Search Alerts/Recalls
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