Catalog Number UNKN05004902 |
Device Problems
Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273); Unintended Electrical Shock (4018)
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Patient Problem
Electric Shock (2554)
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Event Date 11/06/2021 |
Event Type
Injury
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Event Description
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It was reported that, during wound therapy, while using an unknown pico 7 device, the patient experienced electrical shocks.In addition, the device was making abnormal sounds, different from the usual buzzing, and an "electrical burn" smell was perceived.The device was not used in a hyperbaric chamber, mri, nor does the patient have any medical devices that would cause interference.No further information is available.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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It was reported that whilst using an unknown pico 7 the patient experienced electrical shocks in addition the device was making abnormal sounds and an electrical burn smell was perceived.The pump had not been used in a hyperbaric chamber or mri.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.A complaint history review on the product family did not reveal any similar instances in the last three years.As no lot number or product code was provided it was not possible to carry out a device history review.A risk management review determined that although the failure modes are not directly linked to specific failure modes within the risk files there are several failure modes which can result in the reported failure modes and so the risk files mitigate the reported issues with no updates required.A clinical assessment determined that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The most probable root cause for all of the reported failure modes within the event is that the device has been damaged at some point which has caused internal damage to the pump.This damage may then cause all of the described issues, especially if water had become present inside the device also.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.It warns against water or moisture entering the device in section 9.1 and 6.15.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Search Alerts/Recalls
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