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

Model Number OXY-1 CONSOLE

Device Problem Pumping Stopped (1503)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received and an investigation is underway.Upon completion of our investigation, a supplemental mdr will be filed.

Event Description

The complainant reported a (b)(6) female patient presenting covid-19 positive.The oxy-1 breethe system was selected for support.During usage, the console unexpectedly shut down.A nurse reported hearing a "loud alarm" emitting from the device with the lcd screen blacked out.Hand cranking was initiated.The issue was resolved by turning the power switch off, then on again.The patient continued support without further issue.

Manufacturer Narrative

Corrected the following information has been corrected: only check off product problem and not adverse event, as the patient was not injured.Revised catalog number from oxy-1 console to 001-3300-011, update udi to include correct upc.Revised type of reportable event from serious injury to product malfunction as the patient was not injured.Select no for "was device evaluated" as investigation is in process and not yet completed.(b)(4).Check off recall as the device is being recalled.Added recall number.

Manufacturer Narrative

The device was evaluated and we feel the root cause of the reported complaint relates to the esd grounding configuration and/or and component failure.Corrected the following information has been corrected: d(4): corrected console serial and lot number.H(7): removed recall number and 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 13062307
• MDR Text Key: 283692355
• Report Number: 1220648-2021-01215
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 008600017979301
• UDI-Public: (01)008600017979301(10)20210795(11)210617
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXY-1 CONSOLE
• Device Catalogue Number: 001-3300-011
• Device Lot Number: 20210795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2021
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1220648-12/17/2021-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American