Model Number 0684-00-0576-01 |
Device Problems
Inappropriate Waveform (2536); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2021 |
Event Type
malfunction
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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.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, the console displayed a poor fiber optic waveform and the diastolic screen displayed as "0".It was noted that when the pump is in standby, the waveform looks clean and crisp with accurate hemodynamics.The customer attempted recalibrating and also a long flush but there was no change.The customer was advised to get a chest x-ray to confirm placement and to try transducing the central lumen of the balloon catheter.This resulted in a crisp arterial waveform and correct readings of the blood pressure.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Additional information device available for eval changed from yes to no.The device will not be returned to the manufacturer so we are unable to complete an evaluation.If additional information is provided, we will send a supplemental report with the information/.Complaint record id #: (b)(4).H3 other text : device not returned.
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Event Description
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N/a.
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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.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) through (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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