Catalog Number 5C4474 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/09/2015 |
Event Type
malfunction
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Event Description
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It was reported that the patient received an electric shock from the homechoice device.The patient stated that when they opened the door of the device, they got shocked.The technical service representative advised the patient to unplug the device and to perform manual therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).The device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.A short simulated therapy was successfully performed.The reported condition was not verified.The power supply fuse and power cord were replaced preventatively.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).Correction/additional information: additional method code was inadvertently not included in the fu001.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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