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

Model Number	BT-20-0002
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the concentrator flow meter ball drops when used with the life2000 device.There was no injury reported, medical intervention was not required, and there was no oxygen desaturation associated with the reported event.The breathe technologies life2000® ventilation system is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.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 product evaluation is still in process.No further information is available on the investigation 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 supplemental report.
Event or Problem Description
The customer reported that the o2 flow meter ball drops when used with the life2000 device.There was no injury reported, medical intervention was not required, or desaturation associated with the reported event.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
The customer reported that the o2 flow meter ball drops when used with the life2000 device.There was no injury reported, medical intervention was not required, or desaturation associated with the reported event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The device was returned for investigation.Engineering set up an extended range configuration using a known good combo hose, a known good patient circuit, the submitted compressor, and the submitted ventilator.Bled in 5 lpm of oxygen from everflo respironics 5 litter oxygen concentrator.We ran therapies at low, medium, and high activity levels.No error message nor alarms observed.No malfunction found.The compressor performed as intended; it drove the submitted ventilator as intended.The ventilator also performed as intended.Flow meter on our respironics oxygen concentrator did not drop below the 5 lpm set point.Information reviewed reasonably suggests the cause of the reported drop in the concentrator flow meter is possibly related to a system interaction/malfunction between the life2000 and third-party vendor concentrator leading to oxygen flow from the concentrator falling below the prescribed level.A replacement device was sent overnight.If this system interaction/malfunction were to recur, it is likely to cause or contribute to a serious injury.Based on this information, no further action is required.

• 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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18740724
• Report Number: 1316463-2024-00027
• Device Sequence Number: 20640358
• Product Code: CBK
• UDI-Device Identifier: 00887761978201
• UDI-Public: 00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown