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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 Problem Hypothermia (1915)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
The console was not returned by the customer therefore a failure analysis investigation cannot be completed. If device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.
 
Event Description
The complainant reported a (b)(6) male with coid recovered. The breethe ecmo system was selected for support and initiated. The patient's temperature fell to 32. 1 degrees celsius and symptoms of hypothermic occurred for four (4) hours. A bair hugger and warming blankets was used to rewarm the patient.
 
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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 Key12977234
MDR Text Key282561715
Report Number1220648-2021-01182
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier8600017979301
UDI-Public(01)8600017979301(10)2021456368(11)201031
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
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOXY-1 CONSOLE
Device Catalogue NumberOXY-1 CONSOLE
Device Lot Number20210857
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/18/2021
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2020
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: 12/10/2021 Patient Sequence Number: 1
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