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

Model Number 001-3300-011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

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 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.

Manufacturer Narrative

The device was received and the reported issue was successfully reproduced.Our investigation linked the root cause to a defective solid-state drive.D4: fixed erroneous model number, lot number, catalog number, and udi.H7: unchecked "recall".

• Brand Name: OXY-1 CONSOLE
• Type of Device: 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 ; danvers, MA 01923
• MDR Report Key: 13091127
• MDR Text Key: 283693549
• Report Number: 1220648-2021-01217
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 860001797930
• UDI-Public: (01)860001797930(10)20200231(11)201220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-3300-011
• Device Catalogue Number: OXY-1 CONSOLE
• Device Lot Number: 20200231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/17/2021
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1