Catalog Number UNKNOWN |
Device Problems
Filling Problem (1233); Calibration Problem (2890); Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complete initial reporter name: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, a helium leak from the iab occurred.The iab then failed to auto-fill and calibrate.There was no patient harm or adverse event reported.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, a helium leak from the iab occurred.The iab then failed to auto-fill and calibrate.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.The failure modes are addressed in the risk file and are operating within its risk profile.The ifu addresses the reported failures.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #:(b)(4).
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Search Alerts/Recalls
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