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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 10/26/2022 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n h20070045g turns on but, did not work when turned on, needs to be troubleshooting.Out of warranty.There were no procedural delay.No patient involvement.
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Manufacturer Narrative
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Trackwise id (b)(6).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Manufacturer Narrative
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(b)(4).Updated sections: b4, g4, g7, h2, h3, h6, h10 the reported device is an oem device.The certificate of conformance was reviewed for the serial (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.H3 other text : device not returned.
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Event Description
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N/a.
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Search Alerts/Recalls
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