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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Hypothermia (1915)
Event Date 08/27/2021
Event Type  Injury  
Manufacturer Narrative
The console was not returned for evaluation to date. Upon receipt of device, or any new information, a supplemental mdr will be filed.
 
Event Description
The complainant reported a (b)(6) male patient with presenting with covid. The breethe ecmo system was selected for support and initiated without any reported issues. Approximately 2 days into support, the patient's temperature fell to 32 degrees celsius and symptoms of bradycardia and hypo-coagulability were exhibited. As treatment, a bair hugger and warming blankets were placed on the patient for 24 hours until the patient's temperature was brought back up.
 
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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)
BREETHE, INC.
1500 joh ave
suite 190
halethorpe MD 21227
Manufacturer Contact
ralph barisano
22 cherry hill dr.
danvers, MA 01923
MDR Report Key12530004
MDR Text Key273318952
Report Number1220648-2021-01051
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier008600017979301
UDI-Public(01)008600017979301(10)20210795(11)210617
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOXY-1 CONSOLE
Device Catalogue Number001-3300-011
Device Lot Number20210795
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date08/27/2021
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number1220648-12/17/2021-001-R

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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