MAUDE Adverse Event Report: WELCH ALLYN INC LIFE2000 VENTILATOR PACKAGED; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	BT-20-0002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported to have experienced a copd exacerbation and was subsequently hospitalized.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
A patient reported to have experienced a copd exacerbation and was subsequently hospitalized.The patient is an 81-year-old female with a reported medical history of severe chronic obstructive pulmonary disease (copd), chronic respiratory failure requiring home oxygen therapy, obstructive sleep apnea, and anxiety.The patient reported that on an unspecified date, she experienced a copd exacerbation and needed to use the life2000 device.With the assistance of her nephew, the patient was placed on the life2000, but the device allegedly did not deliver air/breaths.The device was reportedly, turned all the way up, and no alarms were noted.The patient¿s husband returned home and called 911.When emergency medical services arrived, the patient was reportedly placed on oxygen and transported to the hospital.While hospitalized for two weeks, the patient reportedly was monitored, administered high flow oxygen, and several unspecified tests were performed.The patient stated she was not placed on bipap or intubated.The patient was reportedly discharged home on regular oxygen via nasal cannula.The patient reported she had not used the life2000 device since the reported incident.The patient indicated she was calling baxter regarding the life2000 field action letter she received.Baxter clinical support attempted to advise the patient that the field action letter was sent to all life2000 patients and the reason for the letter; however, the patient ended the call prior to obtaining complete information and prior to advising the patient not to attempt use of the life2000.The patient did not provide any additional information.The life2000 ventilation system is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.The system is intended for use by qualified, trained personnel under the direction of a physician.Specifically, the system is applicable for adult patients who require the following types of ventilatory support: positive pressure ventilation, delivered invasively (via et tube) or non-invasively (via mask); assist/control mode of ventilation.The device instruction for use state that one should always have an alternate means of ventilation or oxygen therapy available.The device instructions for use (ifu) states ventilation will not begin until an activity button is pressed on the ventilator.Ensure a pressure source (the compressor, an oxygen cylinder, or an oxygen wall source) is connected to the ventilator and turned on.Press and hold an activity button until you hear a tone that indicates it is active.The touch screen will display the home screen and the ventilator will begin delivering therapy.Confirm the selected activity icon is displayed at the bottom of the touch screen and the icon and volume are displayed at the top of the screen.Copd is a chronic inflammatory lung disease that causes obstructed airflow from the lungs.Symptoms include but are not limited to shortness of breath, wheezing, and chest tightness.Patients with copd are likely to experience periods of exacerbation during which symptoms suddenly worsen and may require hospitalization.In this event, the patient reportedly experienced a copd exacerbation requiring medical intervention (hospitalization) to preclude permanent impairment of a body function or permanent damage to a body structure; if one assumes the facts reported by the patient to be true and accurate, one can conclude that a serious injury occurred.Due to the patient not returning the device to baxter, it is undetermined whether the baxter device caused or contributed to the reported event.Should additional information be received, the complaint will be reassessed accordingly.

• Brand Name: LIFE2000 VENTILATOR PACKAGED
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18811033
• Report Number: 1316463-2024-00036
• Device Sequence Number: 3314656
• Product Code: CBK
• UDI-Device Identifier: 00887761978201
• UDI-Public: 00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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?: Yes
• Device Model Number: BT-20-0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female