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 10/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that the decontamination technician noted that the right rear caster was not attached to the device but sitting in the box.It was reattached by the technician.Per sample evaluation result received on (b)(6)2022 , there are signs of electrical overstress at the connection point between the power inlet module and the main voltage circuit card.Per sample evaluation result received on (b)(6)2022 , it was reported that the chiller evaporator outlet tube and double bend tube to the manifold were 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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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.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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Event Description
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It was reported that the decontamination technician noted that the right rear caster was not attached to the device but sitting in the box.It was reattached by the technician.Per sample evaluation result received on 26apr2022, there are signs of electrical overstress at the connection point between the power inlet module and the main voltage circuit card.Per sample evaluation result received on 10oct2022, it was reported that the chiller evaporator outlet tube and double bend tube to the manifold were expanded.
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Search Alerts/Recalls
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