Model Number BL1433 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Information (3190)
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Event Date 11/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device history was reviewed and found to meet manufacturing specification.The investigation is ongoing.
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Event Description
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The user facility in (b)(6) reported during surgery the equipment suddenly stopped when the cassette ejected from the stellaris unit.The cassette was inserted back into the stellaris and the surgery resumed.The procedure was aborted and not completed according to plan and timeline.Additional information has been requested.
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Manufacturer Narrative
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The product was not returned for evaluation, but it was evaluated by the field service engineer on site.It was determined that the problem is the pcb of the pfm module, but this part cannot be replaced separately.Consequently, the module was changed.Therefore, the root cause was determined to be a component issue.This investigation is complete.
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Manufacturer Narrative
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The product was not returned for evaluation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is complete.
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Manufacturer Narrative
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Correction: d4: pfm02513.
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Search Alerts/Recalls
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