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Model Number 50000000E |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2022 |
Event Type
malfunction
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Event Description
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It was reported that the biomed was performing preventive maintenance and the arctic sun device was not cooling.Biomed already heated but could not cool down, chiller temperature (t4) was 20c and confirmed that there was not any water in the chiller tank indicating that the mixing pump had failed.Biomed stated that they had the spare parts inhouse and would replace it onsite.Per email response received on 18-july-2022, no patient involvement during reported event.Per sample evaluation results received on (b)(6) 2022, the arctic sun device was originally short filled.It was noted that the control panel did not boot up but used a user interface to complete decontamination.It was stated that upon investigating, it was discovered that the bios coin cell was depleted.It was also noted that both the double bend tube and the chiller evaporator outlet tube were found to be expanded.
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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 biomed was performing preventive maintenance and the arctic sun device was not cooling.Biomed already heated but could not cool down, chiller temperature (t4) was 20c and confirmed that there was not any water in the chiller tank indicating that the mixing pump had failed.Biomed stated that they had the spare parts inhouse and would replace it onsite.Per email response received on 18-july-2022, no patient involvement during reported event.Per sample evaluation results received on 24-aug-2022, the arctic sun device was originally short filled.It was noted that the control panel did not boot up but used a user interface to complete decontamination.It was stated that upon investigating, it was discovered that the bios coin cell was depleted.It was also noted that both the double bend tube and the chiller evaporator outlet tube were found to be expanded.Per sample evaluation results received on 24jan2023, it was reported that the tank seals were replaced due to lifting from the tank.It was stated that the chiller molded tube was replaced due to damage found during repairs.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.
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Search Alerts/Recalls
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