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Model Number IPN000320 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that a system error 3(2) alarm occurred during use on a patient.As a result, the patient was successfully swapped to a second console, and the first 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).
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Manufacturer Narrative
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Qn# (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of the system error 3 alarm is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial number/lot 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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It was reported, that a system error 3(2) alarm occurred, during use on a patient.As a result, the patient was successfully swapped to a second console.And the first pump was sent to biomed.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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