Model Number SCF312 |
Device Problems
Charred (1086); Device Inoperable (1663); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Product was requested to be returned for evaluation, (b)(6) 2015.
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Event Description
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On (b)(6) 2015 the customer tried to remove the plug from the wall socket and part of the plug stayed in the socket.An electrician was called to the home to remove the plug from the socket.
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Manufacturer Narrative
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Dfu clearly instructs customer to check cables before every single use.This adverse is given in order to prevent incidents that cable is damaged (e.G.By bending) and that customer is exposed to unsafe situation by using each cable pictures us attached eval show that cable was handed and that can cause fracture of the insulation.Customer stated that they were aware that cable was damaged and will choose to use it ("cord was starting wear and plastic was thin and had exposed wires.") in this case, customer didn't follow instructions stated in the dfu.
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Event Description
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(b)(6) 2015, customer claims when she plugged the pump (double electric breast pump) in it popped.
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Manufacturer Narrative
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Product was requested to be returned for evaluation, 09/04/2015 and 09/16/2015.The device has not been returned.This is the first time that such incident is reported.Without receiving plug and complete product for technical investigation and based only on the description of the customer is not possible to clarify the root cause of the incident.Taking into account that no sparking, excessive temperature or other hazardous situations (e.G.Plug is damaged in such way that hv voltage components become accessible) are reported we can conclude that no safety risk occurred.We will monitor possible new cases and take an action if needed.
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Search Alerts/Recalls
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