Catalog Number 500-BAS-UK-10 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Output Problem (3005); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The returned device will be investigated by heartsine.Upon conclusion of the investigation a follow up report will be submitted detailing the findings.
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Event Description
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Child prompts with adult pad-pak has the potential to cause adverse event.No patient was involved in this event.
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Event Description
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Child prompts with adult pad-pak has the potential to cause adverse event.No patient was involved in this event.
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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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