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Model Number 5100004000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
Event Type
malfunction
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Event Description
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The user facility reported that the device had unintended activation during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
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Manufacturer Narrative
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Corrected data: h6.This event was originally reported under stryker vmsr report 0001811755-2021-00154 on (b)(6) 2021 with the device code of 'device remains activated'.Upon completion of the investigation for the device, stryker corrected the device code to 'unintended power up' and replaced the previous vmsr report with this corrected mdr.
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Event Description
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The user facility reported that the device had unintended activation during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
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Search Alerts/Recalls
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