HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number SAM 350P |
Device Problems
Failure to Sense (1559); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Insufficient Information (4580)
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Event Date 07/16/2021 |
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.
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Event Description
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Use of the device may have caused or contributed to an adverse event.A clinical review will be performed to determine device contribution.Patient involved, outcome unknown.Impact of device to be assessed by clinical team.
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Manufacturer Narrative
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The customer provided additional information that the patient died as a result of the event.Sections b1, b2, b5, and h1 have been updated to reflect this update.The device was not returned to heartsine for investigation.No additional information regarding the investigation conclusions will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.
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Event Description
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Complaint alleges that the device failed to operate as intended, and did not progress past apply pads, resulting in adverse consequences.The event was patient involved, death was reported.
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Search Alerts/Recalls
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