Model Number 66801496 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, the vacuum motor was defective for a renasys go, it cannot generate and control negative pressure and it failed the blockage test.No patient harmed, and no injury reported because this was found during service and repair.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment, has been returned and evaluated.The visual evaluation found the outer case is damaged.The functional evaluation found the device failed to generate negative pressure, establishing a relationship with the reported event.The root cause is a defective vacuum pump.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Event Description
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It was reported that the renasys go device cannot generate and control negative pressure and it failed the blockage test.No patient involved, found during service and repair.
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Search Alerts/Recalls
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