Model Number IPN000302 |
Device Problems
Mechanical Problem (1384); Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon pump alarmed for "system error 3, and the pneumatic system stop pumping during the procedure".As a result, staff press the start button again and pump come back to work.There was no report of delay in therapy.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iap part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "system error 3 alarm" is not able to be confirmed.The distributor's field service engineer serviced the pump and no problem was found with pump.The pump passed preventative maintenance (pm).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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon pump alarmed for "system error 3, and the pneumatic system stop pumping during the procedure".As a result, staff press the start button again and pump come back to work.There was no report of delay in therapy.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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