Model Number 53401 |
Device Problems
Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Nonstandard Device (1420); Failure to Read Input Signal (1581)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis found that the output dial failed.As a result the encoder assembly was replaced.A firmware update was also performed.The device then passed all final functional testing.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that a reset to nominal values could be induced on the external pulse generator (epg) by hitting, rubbing or shaking the device.This was noticed only during testing of the device by the technical department in the hospital.The device has been quarantined by the hospital and will not be returned.There was no patient involvement.The device was later returned for a firmware update.It was analyzed and tested out of specification.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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