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

Model Number	OXY-1 CONSOLE
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was obtained from the user facility and an investigation is underway.A supplemental mdr will be filed upon completion of the investigation.
Event or Problem Description
The complainant reported a console failure after unboxing the device, during boot up (alarms and frozen screen).There was no patient involved or impacted.
Additional Manufacturer Narrative
The device was returned and an investigation concluded the root cause of the reported complaint was related to a software defect.The following items were corrected: d(4): catalog number and udi.

• Brand Name: OXY-1 CONSOLE
• Common Device Name: ABIOMED 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 Key: 13054126
• Report Number: 1220648-2021-01209
• Device Sequence Number: 13855296
• Product Code: DTZ
• UDI-Device Identifier: 00860001797930
• UDI-Public: (01)00860001797930(10)20200339(11)201027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K200109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OXY-1 CONSOLE
• Device Catalogue Number: 001-3300-011
• Device Lot Number: 20200339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown