Model Number SAM 350P |
Device Problems
No Audible Prompt/Feedback (2282); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Return of the device has been requested for investigation.Upon closure of the investigation a supplemental mdr will be submitted.
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Event Description
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The audio on the device did not function as expected.Audio and membrane prompts are used to assist the user through application of pads, cpr and shock.A delay or dismissal of the device as faulty may occur if the user cannot hear the usual prompts during rescue.No patient was involved in this.
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Event Description
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The audio on the device did not function as expected.Audio and membrane prompts are used to assist the user through application of pads, cpr and shock.A delay or dismissal of the device as faulty may occur if the user cannot hear the usual prompts during rescue.No patient was involved in this.
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Manufacturer Narrative
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The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time.If the device is returned to the manufacturer the investigation will be reopened.
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Search Alerts/Recalls
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