MAUDE Adverse Event Report: RESPIRONICS BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number 1076495

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Patient Problem/Medical Problem (2688)

Event Date 04/24/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient became disconnected from the bipap a40 device.The patient was in cardiac arrest and was transported to the hospital where the patient later died.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient allegedly became disconnected from the bipap a40 device.The patient was in cardiac arrest and was transported to the hospital where the patient later died.The device was returned to the manufacturer for evaluation.The device was found to operate and alarm to design specifications.It was reported later that the mask came off the patient and the patient was taken to the hospital.A review of the device's downloaded event log was completed by the manufacturer.On the day of the reported event, (b)(6)/2018 at 01:32:28 utc the logs indicated the device was alarming for a patient disconnect alarm condition with a duration of 1142 seconds (approximately 19 minutes).The alarm appears to have been acknowledged by the caregiver by logged audio pause key presses.At 10:08:03 utc, the device was again alarming for a patient disconnect alarm condition with a duration of 9180 seconds (approximately 153 minutes).At 13:00:40 utc the alarm was acknowledged by an audio pause key press.The device continued to alarm for patient disconnect alarm condition until the device was powered off at 15:40:09 utc when the device was powered off by the logged power off key press steps.The intended use for the bipap a40 states," the bipap a40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with obstructive sleep apnea (osa), respiratory insufficiency, or respiratory failure.It is intended to be used in home, institutional/ hospital, and portable applications such as wheelchairs and gurneys.It is not intended to be used as a transport ventilator, and is not intended for life support." the manufacturer concludes the device operated and alarmed to design specifications.The device did not cause or contribute to the patient's death.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7491016
• MDR Text Key: 107490248
• Report Number: 2518422-2018-01099
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1076495
• Device Catalogue Number: 1076495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR