Model Number OXY-1 CONSOLE |
Device Problems
Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hypoxia (1918)
|
Event Date 11/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The console and pump used in this case was returned by the customer and a failure analysis investigation is underway.A supplemental mdr will be filed at the completion of the device's investigation.
|
|
Event Description
|
The complainant reported a (b)(6) white male with covid.The breethe ecmo system was selected for support and initiated.The console shut off, total time without support was 2-3 minutes, saturations dropped to the low 50s, and there was transient hypoxia.
|
|
Manufacturer Narrative
|
The device was evaluated and we feel the root cause of the reported complaint relates to the esd grounding configuration and/or component failure.The following corrections have been made: d(4): revised catalog, lot, and udi.H(6): removed 2993 from medical device problem code and add 1503 - pumping stopped.
|
|
Search Alerts/Recalls
|