Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device was not returned to physio control.The third-party service agent evaluated customer's device and verified the reported issue.After replacing the therapy pcb assembly and performing some unrelated repairs proper device operation was observed through functional and performance testing.The device was subsequently returned to customer for use.
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Event Description
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A customer contacted physio-control to report that their device had illuminated its service led and had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.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 replaced therapy pcb assembly and verified the reported issue.The cause of the reported issue was determined to be due to shorted pins 5 to 9 of diode, designator cr30, which resulted in partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.
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Event Description
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A customer contacted physio-control to report that their device had illuminated its service led and had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Event Description
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A customer contacted physio-control to report that their device had illuminated its service led and had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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