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Catalog Number IAP-0700 |
Device Problem
Connection Problem (2900)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported " iab pump died when unplugged.The user saw stacked alerts of battery life < 20mins, < 10 mins and < 5 mins".Additionally it was reported that "patient did not sustain injury or expire".To complete/continue therapy, the pump was exchanged for another console prior to traveling to the or.The patient's current condition is reported as "critical" please see associated mdr #3010532612-2024-00225.
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Manufacturer Narrative
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(b)(4).The reported complaint of "pump died when unplugged" is not able to be confirmed.No part or recorder strip was returned to teleflex chelmsford for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.
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Event Description
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It was reported " iab pump died when unplugged.The user saw stacked alerts of battery life < 20mins, < 10 mins and < 5 mins".Additionally it was reported that "patient did not sustain injury or expire".To complete/continue therapy, the pump was exchanged for another console prior to traveling to the or.The patient's current condition is reported as "critical".Associated mdr #3010532612-2024-00225.
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Search Alerts/Recalls
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