Model Number 50000000 |
Device Problems
No Display/Image (1183); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
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.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 there was no display in the monitor of arctic sun device and therapy was completed on the second device.Per follow up information received on 12-aug-2022, this device was not used on patients and the screen was blank.
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Manufacturer Narrative
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Upon investigation findings, bd has determined that this mdr was not reportable.H11: section a through f - the information provided by bard 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 bard.
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Event Description
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It was reported that there was no display in the monitor of arctic sun device and therapy was completed on the second device.Per follow up information received on 12-aug-2022, this device was not used on patients and the screen was blank.
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Search Alerts/Recalls
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