Catalog Number 500-BAS-CN-10 |
Device Problems
Failure to Power Up (1476); Electrical Power Problem (2925); Failure to Shut Off (2939)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Event Description
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Device will not switch on.No patient involvement.
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Event Description
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Device will not switch on.No patient involvement.
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Manufacturer Narrative
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The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.H3 other text: device not evaluated by manufacturer.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault, as upon receipt the device could not be powered on.This fault was attributed to membrane failure due to suspected storage outside of the indicated conditions.The corrosion observed on the membrane pcb would indicate the device had been stored outside of the indicated conditions.However, this could not be verified by other means, as there was no corrosion observed on the exterior of the device.Whilst the device could provide a test shock during the investigation, failure to power on a device may prevent or delay defibrillation therapy, which could result in adverse consequences.
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Event Description
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The customer contacted heartsine to report that their device will not switch on.Inability to switch on a device may prevent or delay defibrillation therapy.The was no patient involvement reported with the event.
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Search Alerts/Recalls
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