HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 350P |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report a non-critical issue with their device.During evaluation, a pogo pin failure was found.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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The customer contacted heartsine to report a non-critical issue with their device.During evaluation, a failed pogo pin was observed.The failed pogo pin had resulted in a poor connection between the device and pad-pak, resulting in voltage fluctuations and low battery fails from the (b)(6) 2022.The user would have been alerted with ¿warning, low battery¿ prompt alongside a flashing red status indicator and failure chirp, as per the reported fault.This fault was attributed to a pogo pin failure.The device was scrapped by heartsine and the customer was provided with a replacement device.
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