HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, 1X PAD-PAK-03, ICELANDIC, 350-STR-IS-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 350P |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2023 |
Event Type
Death
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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.Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.
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Event Description
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The customer contacted heartsine to report that their device may not have delivered a shock.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.
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Search Alerts/Recalls
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