Catalog Number 500-BAS-UK-10 |
Device Problems
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 07/14/2021 |
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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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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Manufacturer Narrative
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Heartsine's investigation confirmed the reported fault as the device was found to be giving incorrect child patient prompts with an adult pad-pak installed.The investigation determined a failure of the reed switch which controls whether the device recognises an adult or child patient pad-pak insertion.If an child patient is detected but an adult is connected, the higher the impedance the lower the shock energy.There is potential to cause an adverse event but it is dependent on the impedance of the patient.
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Search Alerts/Recalls
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