MAQUET CARDIOVASCULAR LLC HEMOPRO 2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VH-4030 |
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 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(4).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.
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Event Description
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Related record: (b)(4).The hospital reported that hemopro2 extension cable vh-4030 would not work (no power).No power to hemopro 2, changed out to another adapter vh-4020 no difference.Changed to another vh-4030 no difference, and then changed to a third vh-4030 and it worked.No delays reported.No patient effects 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.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
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Search Alerts/Recalls
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