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Model Number 50000000 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
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 biomed stated they received an error code ¿control processor failed to detect" and "turn off control module" during calibration on the arctic sun device.Per additional information received on 28-dec-2021, biomed stated they ordered and replaced the i/o circuit card, and the alarm was persisting.Mss suggested an assessment quote to accurately assess the device.Biomed stated they received an error code ¿control processor failed to detect" and "turn off control module".Per follow up information received on 06-jan-2022, biomed stated that there was no patient involved and replaced the circuit card onsite and it did not fix the problem.Biomed was now going to send the arctic sun device to the depot for repairs.Per sample evaluation results received on 29-jun-2022, it was noted that upon power up, the alarm 81 monitor processor failed to detect a simulated water temperature.
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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 cascading failure of an event previously reported.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 stated they received an error code ¿control processor failed to detect" and "turn off control module" during calibration on the arctic sun device.Per additional information received on (b)(6) 2021, biomed stated they ordered and replaced the i/o circuit card, and the alarm was persisting.Mss suggested an assessment quote to accurately assess the device.Biomed stated they received an error code ¿control processor failed to detect" and "turn off control module".Per follow up information received on (b)(6) 2022, biomed stated that there was no patient involved and replaced the circuit card onsite and it did not fix the problem.Biomed was now going to send the arctic sun device to the depot for repairs.Per sample evaluation results received on (b)(6) 2022, it was noted that upon power up, the alarm 81 monitor processor failed to detect a simulated water temperature.
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Search Alerts/Recalls
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