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Model Number T.W. POWER SUPPLY |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(6).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device not returned.
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Event Description
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The hospital reported no power to the t.W.Power supply.They exchanged the generator to complete the case.No patient effect was reported.
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Manufacturer Narrative
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Trackwise # (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A serial number was not provided and the specific product serial/ lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
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Event Description
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N/a.
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Search Alerts/Recalls
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