Model Number HDF-3500 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
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.The hdf-3500 device is not available for distribution in the united states but is similar to the sam 350p and 450p which is distributed in the united states.Heartsine contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.
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Event Description
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The distributor contacted heartsine to report that their customer's device would not progress past "apply pads".In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Heartsine's investigation of the device was unable to confirm the reported fault.The device underwent extensive testing of all critical functions, performing to specification throughout.During the testing, the device was able to detect an in-range patient impedance and deliver shocks to specification.As no fault could be found on the returned defibrillator, the fault was attributed to a potential use error.
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Event Description
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The distributor contacted heartsine to report that their customer's device would not progress past "apply pads".In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Search Alerts/Recalls
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