Model Number 53401 |
Device Problems
Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Nonstandard Device (1420)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: analysis found that the device required a firmware update.It was also noted that the display current test failed.The display was replaced.The device then passed final 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.The device 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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