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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABIOMED, INC. OXY-1 CONSOLE ABIOMED BREETHE OXY-1 SYSTEM

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ABIOMED, INC. OXY-1 CONSOLE ABIOMED BREETHE OXY-1 SYSTEM Back to Search Results
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.
 
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Brand NameOXY-1 CONSOLE
Type of DeviceABIOMED BREETHE OXY-1 SYSTEM
Manufacturer (Section D)
ABIOMED, INC.
22 cherry hill dr
danvers MA 01923
Manufacturer (Section G)
ABIOMED, INC.
22 cherry hill dr
danvers MA 01923
Manufacturer Contact
ralph barisano
22 cherry hill dr
danvers, MA 01923
MDR Report Key13003181
MDR Text Key283694006
Report Number1220648-2021-01191
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier860001797930
UDI-Public(01)860001797930(10)20210798(11)210713
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200109
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOXY-1 CONSOLE
Device Catalogue Number001-3300-011
Device Lot Number20210859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/22/2021
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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