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 01/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the pump alarmed system error 3.As a result, the pump was swapped out 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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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 system error 3 is not able to be confirmed.According to the field service report, the cmp and mforce were replaced by the hospital's biomed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the 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 the pump alarmed system error 3.As a result, the pump was swapped out and the reported 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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