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

Model Number	BT-20-0002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged that the patient¿s life2000 device alarmed and stopped working and the patient experienced oxygen desaturation.At the time of the reported event, the patient stated the life2000 had a yellow alarm that turned red, and the device stopped giving breaths.The patient tried walking to her oxygen tank but did not have the nasal cannula tubing to go with it and began feeling delirious.The patient called 911 and was reportedly without oxygen for 20-25 minutes.The patient¿s spo2 at the time of the event was not reported.When ems arrived, the patient was placed on oxygen (liter flow not reported), and she felt better.The patient declined being transported to the hospital.In this event, the patient was reportedly without supplemental oxygen for approximately 20-25 minutes and became symptomatic.It can be reasonably concluded that the patient experienced oxygen desaturation, which was life threatening and required medical intervention (assistance from ems, supplemental oxygen) to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
The life2000 ventilator, compressor, and patient circuit were returned to baxter for inspection.The returned devices were set up in an extended range configuration using a known good combo hose.The compressor did not provide pressure and as a result, the ventilator could not produce a breath, which confirmed the customer reported event.A review of the device event history showed a series of low source gas pressure alarms followed by a critically low source gas pressure alarm on the day of the reported event.Using a known good compressor, therapies were run at low, medium, and high activity levels.No error message or alarms were observed, and no malfunction was found.The devices performed as intended.End of line testing (following a specific verification protocol, this testing is done to show the devices meet all performance requirements) was performed on the returned ventilator and compressor and the compressor malfunctioned.The dryer cylinder inside the compressor was loose on both ends, thereby creating a loss of pressure most likely caused by excessive vibration.The ventilator functioned as intended during end of line testing.The cause of the ventilator not providing breaths was determined to be due to a compressor malfunction; however, the ventilator functioned as intended and provided appropriate notification to the patient of a condition that required attention.It would be unlikely to cause or contribute to a death or serious injury if it were to recur.The device ifu provides the following instruction related to a low gas pressure notification: if a low gas pressure alarm is not resolved, place the patient on an alternate means of ventilation (if necessary).The patient in this event did not have an alternate means of ventilation or oxygen therapy available after the life2000 ventilator stopped providing breaths and the patient became symptomatic.The cause of the oxygen desaturation can be attributed to use error as the patient reported she did not have a nasal cannula and her back up oxygen tank was empty.

• Brand Name: LIFE2000 VENTILATOR PACKAGED
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 20761554
• Report Number: 1316463-2024-00154
• Device Sequence Number: 18283043
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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?: No
• Device Model Number: BT-20-0002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female