Model Number 106531US |
Device Problems
Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient needed a new controller due to wear and tear and the green light not being visible (dim led).When the new controller was opened to insert the emergency backup battery (ebb), the ebb connecting ribbon was disconnected.A different controller was used for the controller exchange.Related mfr: 2916596-2022-12507.
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Event Description
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It was reported that there was also an out of box failure for the system controller.The white ribbon inside of the controller was completely dislodged from it's placement.The issue resolved after exchanging the controller.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported events of a dim pump running led and damage were unable to be confirmed.The extent of the damage to the controller was unable to be confirmed.The root cause of the reported events was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 05oct2018.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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