Model Number 20 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control evaluated the customer's device and the reported issue was verified and duplicated.Physio replaced the system controller pcb assembly and the user interface (ui) pcb assembly, which resolved the reported issue.Other unrelated repairs were completed and proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
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Event Description
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The customer contacted physio-control to report that their device would not complete the boot-up process and the device would lock up.As a result, the need for therapy and/or ability to provide therapy could have been delayed or prevented, if it had been necessary.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control further evaluated the removed system controller pcb assembly and verified the reported issue.However after further testing the reported issue could not be duplicated.The removed user interface pcb assembly was an ancillary part and there was no failure of this assembly.
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Event Description
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The customer contacted physio-control to report that their device would not complete the boot-up process and the device would lock up.As a result, the need for therapy and/or ability to provide therapy could have been delayed or prevented, if it had been necessary.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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