HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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Model Number 350P |
Device Problem
Failure to Analyze Signal (1539)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
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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The customer contacted heartsine to report that their device issued "shock advised" prompts but did not allow the user to deliver a shock.In this state the device may not be able to deliver defibrillation therapy if needed.The patient involved in the reported event is deceased; however, the customer advised heartsine that the device used did not contribute to the outcome of the patient.
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