Model Number 50000000 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.
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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.
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Event Description
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It was reported that during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.Per sample evaluation result received on 15jun2022, the water injection tube was clogged and replaced the water injection tube.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was duplicated during evaluation.The device was evaluated and the reported issue was not able to be confirmed as the issue was not duplicated during testing.No repairs for the reported issue were made.The water injection tube is clogged.Replaced the water injection tube.Device underwent calibration and functional check.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.The device history record review was not required as the reported issue was unconfirmed and not a manufacturing or supplier related failure.Labeling review was not required as the reported event is unconfirmed, h11:section a through f - the information provided by bd represents all of 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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Search Alerts/Recalls
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