Model Number 15 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
The third party service agent downloaded the device's electronic records and provided them to physio-control for review.
Upon review, physio-control was able to verify the reported issue.
Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.
56.
Device not evaluated by manufacturer.
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Event Description
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It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on.
The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process.
As a result, defibrillation would not have been possible if it had been necessary.
There was patient use associated with the reported event.
The patient was delivered to the hospital in stable condition.
There were no reports of adverse effects to the patient as a result of the reported issue.
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Manufacturer Narrative
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The third party service agent evaluated the customer's device but was unable to duplicate the reported issue.
The service agent observed that the battery pin in battery well #1 was visibly lower that the other battery pins.
If the battery pin in battery well #1 was making intermittent contact with the battery, this could result in an intermittent loss of power.
The service agent repaired the device by replacing the rear case assembly.
Additionally, the system pcb assembly was replaced as a precaution.
After observing proper device operation through functional and performance testing the unit was returned to the customer for use.
The device was not returned to physio-control for evaluation.
The cause of the reported issue could not be conclusively determined.
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Event Description
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It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on.
The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process.
As a result, defibrillation would not have been possible if it had been necessary.
There was patient use associated with the reported event.
The patient was delivered to the hospital in stable condition.
There were no reports of adverse effects to the patient as a result of the reported issue.
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Search Alerts/Recalls
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