Model Number 1000 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was not returned to physio-control for evaluation.A third-party service agent evaluated the device and verified the reported issue.It was determined that the device was no longer under warranty and not field serviceable.The cause of the reported issue could not be determined.
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Event Description
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The customer sent their device to a third party service agent for the completion of a technical service update (tsu).There were no reports of patient use associated with the reported event or any issues with the device prior to being sent to the service agent.Upon evaluation of the customer¿s device, the third party service agent observed that the device would not complete the boot-up cycle in order to power on, despite showing ¿ok¿ on its readiness display.
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Event Description
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The customer sent their device to a third party service agent for the completion of a technical service update (tsu).There were no reports of patient use associated with the reported event or any issues with the device prior to being sent to the service agent.Upon evaluation of the customer¿s device, the third party service agent observed that the device would not complete the boot-up cycle in order to power on, despite showing ¿ok¿ on its readiness display.
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Manufacturer Narrative
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The customer agreed to ship the device to physio-control for further root cause analysis.Physio-control evaluated the customer's device and verified the reported issue.The cause of the reported issue was determined to be due to a failure of the digital pcb assembly.
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Search Alerts/Recalls
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