MAUDE Adverse Event Report: BREATHE TECHNOLOGIES LIFE2000 VENTILATOR PACKAGED; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number BT-20-0002

Device Problem Non Reproducible Results (4029)

Patient Problem Myocardial Infarction (1969)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to breathe technologies for evaluation.Device evaluation.The technician performed an end of line final test on the device.The final test datasheet showed that all 27 out of 27 parameters tested and passed successfully.Additionally, the software and an event/alarm of the ventilator were reviewed.The event/alarm log shows no faults, no errors.A hardware diagnostic test showed no malfunction of the device.There is no evidence of malfunction of the ventilator.The conclusion of the product evaluation is that the ventilator performed as designed.Hillrom is reporting the patient serious injury in an abundance of caution, as it can not be ruled out that the device caused or contributed to the event.Based on this information, no further action is required.

Event Description

Hillrom received a report from the customer that while using the device, it stopped pumping oxygen and sucked all the air out of her.The customer reported she was unable to get her home oxygen back on when the event occurred.The patient's husband called an ambulance and the patient was transported to the hospital.She was immediately placed on a ventilator and admitted to the intensive care unit (icu).The patient noted she had a heart attack; however, it was unknown when the heart attack occurred and what treatment was provided for the heart attack, as the patient was unconscious and vented for five days.The patient stated the heart attack either happened when the device stopped pumping oxygen, when she got into the ambulance, or upon arrival to the hospital.The patient moved into a step down cardiac floor from the icu and was discharged 12 days after admittance to the hospital.The patient's current status was reported as "weak." the device was located at the patients home.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: LIFE2000 VENTILATOR PACKAGED
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): BREATHE TECHNOLOGIES; 15091 bake pkwy; irvine CA 92618
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 11287078
• MDR Text Key: 230546062
• Report Number: 3008778542-2021-00001
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BT-20-0002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR