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Model Number 50000000 |
Device Problems
Computer Software Problem (1112); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2022 |
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.
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Event Description
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It was reported that the arctic sun device would not fill.A functional check showed that the circulation pump would not generate pressure.They would like to send the device in for a 2k hour service.Per follow up via phone 30jun2021, biomed did not know whether the issue was found during therapy or during maintenance.Per sample evaluation, it was reported that the circulation pump motor was locked and the axel would not turn.When attempting to upgrade the software from version 2.0.1 to version 3.0.2 at end of service, device received an error and could not save parameters to the hard drive.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the arctic sun device would not fill.A functional check showed that the circulation pump would not generate pressure.They would like to send the device in for a 2k hour service.Per follow up via phone 30jun2021, biomed did not know whether the issue was found during therapy or during maintenance.Per sample evaluation, it was reported that the circulation pump motor was locked and the axel would not turn.When attempting to upgrade the software from version 2.0.1 to version 3.0.2 at end of service, device received an error and could not save parameters to the hard drive.Circulation pump motor was replaced.Control panel was replaced.Mixing pump was serviced.Heater was replaced.Drain valves were replaced.Per sample evaluation results received on 30aug2022, it was reported that installed test mixing pump to cool.
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Search Alerts/Recalls
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