Catalog Number 50000000E |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that biomed had a arctic sun device that was failed the calibration for an error 80 (water check time out - unable to reach calibration temperature) expected 6 actual 25.They replaced the mixing pump because chiller temperature (t4) was cold but now the chiller was not powering on.They checked the connections and everything seems to be connected, it would came in for service.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that biomed had a arctic sun device that was failed the calibration for an error 80 (water check time out - unable to reach calibration temperature) expected 6 actual 25.They replaced the mixing pump because chiller temperature (t4) was cold but now the chiller was not powering on.They checked the connections and everything seems to be connected, it would came in for service.
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Search Alerts/Recalls
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