Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Injury (2348)
|
Event Type
Injury
|
Manufacturer Narrative
|
(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 # (b)(4).
|
|
Event Description
|
Complaint received via medwatch report # (b)(4) on 16-jun-2020.There was a leaking error when using maquet/datascope intra-aortic balloon pump that was cancelled last night and today.The patient was found to have air in the iliac arteries on ct.Iabp (intra-aortic balloon pump) was removed.Iabp was sequestered and biomed work order was put in for further evaluation/inspection.Date of event - (b)(6) 2019.
|
|
Event Description
|
Complaint received via medwatch report # (b)(4) on 16-june-2020.There was a leaking error when using maquet/datascope intra-aortic balloon pump that was cancelled last night and today.The patient was found to have air in the iliac arteries on ct.Iabp (intra-aortic balloon pump) was removed.Iabp was sequestered and biomed work order was put in for further evaluation/inspection.Date of event - (b)(6) 2019.
|
|
Manufacturer Narrative
|
Section d - device available for eval? from: yes, to: no.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.Reference complaint #: (b)(4).
|
|
Search Alerts/Recalls
|