Model Number 102954 |
Device Problem
Electrical Power Problem (2925)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2024 |
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.Section e1: reporter address line 1: (b)(6).Section e1: reporter postal office or zip code: (b)(6).
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Event Description
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It was reported that the motor stopped and got very hot.
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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 additionally reported that the equipment was in use on a bi-ventricular assist device (vad) patient and ran for a couple of weeks with no issue.There was suddenly a drop in flow approximately 4 liters per minute to zero flow with zero revolutions, and then immediately went back up to 4 liters per minute.A couple second later the pump flow dropped to zero flow again with zero revolutions and did not recover.The extracorporeal membrane oxygenation (ecmo) coordinator performed an emergency motor change, which involved changing the console and flow probe.The faulty group of equipment was removed.It was noted that the motor was very hot to touch and took a long time to cool down.The patient received some downtime without ecmo flow but had enough heart reserve to cope while the motor was changed out.
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Search Alerts/Recalls
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