Model Number 66801496 |
Device Problems
Defective Alarm (1014); Failure to Charge (1085); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, a renasys go, did not operate on ac o battery power and cannot recharge the battery.Also, the device neither generate nor control negative pressure.Also the device does not generate alarms under expected alarm conditions.As this was noticed upon service and repair activities, there was not patient involvement.
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Manufacturer Narrative
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The device, intended to be used in treatment, has been returned for evaluation.Device emitted a bad odor.Visual inspection of device found defects to outer case.Functional evaluation found that the device was unable to operate on ac or battery power or be recharged.Device was also unable to generate alarms under the expected alarm conditions or generate and control negative pressure, establishing a relationship between the device and the reported event.Root cause of the defective alarm and the suction failure found to be a defective main circuit board in the device, with the root cause of the failure to charge found to be a broken dc inlet port.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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