Model Number 350P |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2023 |
Event Type
malfunction
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Event Description
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A distributor contacted heartsine to report that a customer¿s device did 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 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.Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
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Manufacturer Narrative
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Heartsine evaluated the customer's device but was unable to duplicate the reported issue.There was no fault found with the device.No continuity issue was identified on the patient output cables and no fault found on the pogo pins that would have resulted in an impedance detection issue.The device accurately measured impedances throughout the specified range, even under the stress of elevated temperature.Given no fault found on the aed or returned pad-pak and no further information provided by the customer, the investigation was unable to determine how the reported fault could have occurred.It can only be suggested that this due to situational factors.E.G., a pad-pak fitment issue or incorrect placement of pads on the patient.The device was retained by heartsine.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device did 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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