Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no additional information was provided.
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Event Description
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The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
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Event Description
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The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
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Manufacturer Narrative
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Physio-control further evaluated the replaced ui pcba and system pcba at the product analysis center (pac) and no defect were found, both boards are functional.The cause of the reported issue could not be determined.
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Manufacturer Narrative
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A third party service provider evaluated the customer's device and verified reported issue.The user interface pcb and system pcb were replaced.The device passed functional and performance inspection and was returned to the customer.The third party service provider was contacted numerous times for component return, no response has been received.The components have not been returned to stryker for evaluation.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
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Search Alerts/Recalls
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