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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 10/18/2021
Event Type  Injury  
Event Description
The complainant reported a (b)(6) female patient presenting as covid+ for ecmo support. During support, the patient endured a "clinically significant" episode of hypothermia with core temperature sinking to 35 degrees centigrade. Attempts to rewarm the patient were made via a bairhugger, however, to no avail. The patient was removed from the system and replaced with another ecmo unit with heating capabilities.
 
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.
 
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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
baltimore MD 21227
Manufacturer Contact
ralph barisano
22 cherry hill dr.
danvers, MA 01923
MDR Report Key12820024
MDR Text Key280885524
Report Number1220648-2021-01139
Device Sequence Number1
Product Code DTZ
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
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
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 Number20200352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/18/2021
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
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