Model Number IPN001112 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, a burn mark/melted connector cable was noted on the motor driver connector and on the motor driver cable.The returned device was too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.
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Event Description
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It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) gave the error 3 pump/controller failure prior to use on a patient during inspection/functional testing.As a result, the customer used another functioning iabp.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn#: (b(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, a burn mark/melted connector cable was noted on the motor driver connector and on the motor driver cable.The returned device was too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.
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Event Description
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It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) gave the error 3 pump/controller failure prior to use on a patient during inspection/functional testing.As a result, the customer used another functioning iabp.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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