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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 12/06/2022 |
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 biomed had a device which had a weak circulation pump, the device had 7915 system hours, till need the 2k preventative maintenance done either by him or our depot.As per sample evaluation result received on 06dec2022, it was reported that the tank tubing was noted to be expanded.
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Event Description
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It was reported that the biomed had a device which had a weak circulation pump, the device had 7915 system hours, till need the 2k preventative maintenance done either by him or our depot.As per sample evaluation result received on 06dec2022, it was reported that the tank tubing was noted to be expanded.As per sample evaluation result received on 06dec2022, it was reported that the tank tubing such as l shape formed tube and double bend tube were expanded.It was noted that the l shape formed tube and double bend tube were replaced.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr event is not reportable.H11: section a through f - 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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Search Alerts/Recalls
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