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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 Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
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 the console was to replace a failing console, upon start up the "breethe" logo screen stayed in for one (1) minute and thirty (30) seconds, and then went blank. Multiple attempts to reboot but the same outcome reoccurred.
 
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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 Key13043630
MDR Text Key283694278
Report Number1220648-2021-01206
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier860001797930
UDI-Public(01)860001797930(10)2021456733(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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
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 Number2021456733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date08/17/2021
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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