Model Number IPN000320 |
Device Problem
Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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Prior to use on a patient during inspection/functional testing.It was reported that the iabp machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "unable to power-up" is confirmed.The pump displayed blank screen with no voltage outputs during testing.The root cause of the power supply voltage output failure 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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Event Description
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Prior to use on a patient during inspection/functional testing.It was reported that the iabp machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure.
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Search Alerts/Recalls
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