Catalog Number 00-5150-475-00 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/16/2013 |
Event Type
malfunction
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Event Description
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It was reported that the pulsavac plus wound debridement system fan spray kit was not able to be switched for both high or low speed fluid trigger.There was no patient harm or delay reported, and the procedure was completed with an alternate device.
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Manufacturer Narrative
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The device was returned to the manufacturer for evaluation.A review of the manufacturing records was performed and there were no non-conformances during manufacture that would be related to this complaint.All testing requirements were met.The trigger was found in the low mode position as received.The complaint was confirmed.The unit would not function on high or low mode.The battery case was opened and found to have 1 battery (position 5) that had vented on the negative terminal causing corrosion.Both the battery and battery pack terminal showed corrosion on the negative end.The wiring was analyzed and no issues were identified.All battery voltages were tested and were all found to be exhausted.New batteries were placed in the battery pack and the unit was tested.It functioned normally in high and low modes.The cause of the reported issue was the battery had leaked its contents causing corrosion.The cause of the defective battery is unknown.The device was serviced and returned to the customer.
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Search Alerts/Recalls
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