Catalog Number 500-BAS-UK-10 |
Device Problems
Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Inadequacy of Device Shape and/or Size (1583); Device Sensing Problem (2917); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
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Event Description
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As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient which may result in adverse consequences.No patient involvement.
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Event Description
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The distributor contacted heartsine to report that their device was prompting child pad when the adult pad-pak was inserted.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient which may result in adverse consequences.There was no patient involvement reported with this event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as the device was found to be giving incorrect child patient prompts with an adult pad-pak installed.The reported fault was root caused to a failure of the reed switch, as the measurements taken during the investigation indicated this failure mode.Whilst the device could deliver a test shock during the investigation, as patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient which may result in adverse consequences.
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Search Alerts/Recalls
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