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Model Number IPN001112 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2022 |
Event Type
malfunction
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Event Description
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It was reported by the clinical support specialist (css) that after a "large helium loss" alarm, the pump stopped pumping without any alarm, and the screen went black.The staff tried to power the pump back on, but the screen would not return.As a result, the staff swapped the pump, and the reported pump was sent to biomed.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported by the clinical support specialist (css) that after a "large helium loss" alarm, the pump stopped pumping without any alarm, and the screen went black.The staff tried to power the pump back on, but the screen would not return.As a result, the staff swapped the pump, and the reported pump was sent to biomed.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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Qn# (b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of "pump stopped pumping and screen went blank" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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