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

Model Number BT-20-0002

Device Problem Accessory Incompatible (1004)

Patient Problem Burning Sensation (2146)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

The patient reported that her inogen home oxygen concentrator (3rd party) was "alarming and acting up" and that she was experiencing a burning sensation in her nares.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The patient reported that her inogen home oxygen concentrator (3rd party) was "alarming and acting up" and that she was experiencing a burning sensation in her nares.No medical intervention was required.The patient utilizes the life 2000 device in conjunction with her inogen oxygen concentrator and attributes the life 2000 device to the oxygen concentrator issue.The patient is contacting her healthcare provider to obtain a new oxygen concentrator.The patient is a 59-year-old female with relevant history of interstitial pulmonary disease.The life 2000 ventilation system is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.The device's combo2 hose may be used to connect the life2000® ventilation system in the extended range configuration and provide supplemental low-flow oxygen from an oxygen concentrator or other low-flow oxygen source.The l2k device ifu notes "for any accessories, read the label and accompanying document(s) before use." a burning sensation in the nares is the result of irritation to the nasal cavity and can be caused by a variety of factors including oxygen supplementation, cold, dry air, or sinusitis.Medical intervention is not required, nasal lubrication spray or humidified air may help alleviate the symptom.In this event, there was no report of permanent impairment of body function or damage to body structure, and no medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, therefore, a serious injury did not occur.The ultimate cause of the reported burning sensation and issues with the oxygen concentrator is unknown.Due to pending inspection at this time, a system interaction/malfunction between the life2000 and third-party vendor concentrator cannot be excluded.If a system interaction/malfunction were to recur, it is likely to cause or contribute to a serious injury.If any additional relevant details are received the complaint will be addressed accordingly.No further information is available on the repair of the device at this time.¿ the investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a final report.

Manufacturer Narrative

Inspection by a hillrom technician found the ventilator functioned as designed.Testing included setting up an extended range configuration using a known good combo hose, a known good patient circuit, a known good compressor, and the submitted ventilator.They ran therapies at low, medium, and high activity levels.No error message nor alarms observed; no malfunction found.The ventilator performed as intended.They did not see any evidence that the submitted ventilator contributed to the alleged ¿nasal burns¿.Allegations of injury could not be duplicated.In this event, there was no report of permanent impairment of body function or damage to body structure, and no medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, therefore, a serious injury did not occur.An inspection of the life2000 device indicated the device worked as intended.At present, hillrom is unable to rule out if a system interaction/malfunction between the life2000 and third-party vendor oxygen concentrator is likely to lead to a serious injury if the event were to recur.

Event Description

The patient reported that her inogen home oxygen concentrator (3rd party) was "alarming and acting up" and that she was experiencing a burning sensation in her nares.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): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16807307
• MDR Text Key: 313927664
• Report Number: 1316463-2023-00101
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BT-20-0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 59 YR
• Patient Sex: Female