Catalog Number 0684-00-0575 |
Device Problems
Device Damaged Prior to Use (2284); Moisture or Humidity Problem (2986)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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.(b)(4).
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Event Description
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It was reported that prior to use of the intra-aortic balloon (iab), 5 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #5 of the 5 devices.
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Manufacturer Narrative
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Added device return date.Record id: (b)(4), autonumber: (b)(4).
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Event Description
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It was reported that prior to use of the intra-aortic balloon (iab), 5 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #5 of the 5 devices.
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Manufacturer Narrative
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No decon or visual inspection of product performed since product was not returned.A review of the provided photographs confirms the damage to the shipping and user cartons inside of it.The product was not returned and so could not be evaluated.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The event is confirmed based on a review of the provided photographs.The most likely cause is damage that occurred during shipping or handling of the outer shipping carton.Complaint record id # (b)(4).Device not returned.
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Event Description
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It was reported that prior to use of the intra-aortic balloon (iab), 5 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #5 of the 5 devices.
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Manufacturer Narrative
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A visual inspection of the returned product and provided photos determined that the packaging had suffered both physical and water damage.The evaluation confirms the reported problem.We are unable to conclusively determine when this may have occurred, but it is likely to have occurred during shipping or storage.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Record id: (b)(4), autonumber: (b)(4), s/n: (b)(6).
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Event Description
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It was reported that prior to use of the intra-aortic balloon (iab), 5 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #5 of the 5 devices.
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Search Alerts/Recalls
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