Model Number BEQ-HLS 7050 USA#HL |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Product requested but not yet returned.
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Event Description
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According to the customer: after installation of hls set the delta p started off at 30.Once problem was realized, the circuit was emergently changed out and the patient stabilized.Customer claims this was a possible defect of the disposable but it could be also have been patient related.No harm to the patient was reported.(b)(4).
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Manufacturer Narrative
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Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person- (b)(6).Maquet cardiopulmonary gmbh requested the product for investigation but the product was not available.Already scrapped by the customer.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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Event Description
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Internal reference: (b)(4).
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Search Alerts/Recalls
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