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Model Number IPN000325 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/26/2021 |
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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There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline and helium loss alarm" is not confirmed.The returned m-force motor driver assembly passed visual and functional test specifications.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 revised risk.This will be monitored for any developing trends.
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Event Description
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There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.
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Search Alerts/Recalls
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