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

Model Number CN1111169

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Insufficiency (4462)

Event Date 05/01/2023

Event Type  Death  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging a ventilator mask fell off of the patient causing the patient's death.At that time, the local government was contacted for follow up, and the engineer arrived at the scene to find out that it was not a ventilator problem.The family has mentioned this matter again and involved a medical dispute.The customer (user facility) has called for consultation.Per the philips clinical expert's review: based on information provided and available, this event is assessed as an unintentional user error ¿ mask fell off and was not placed back on the patient.If the patient was placed on the bipap a40 for life sustaining measures, the mask being taken off and not placed back on would ultimately result in the patient's death and be an expected consequence of inadequate oxygenation to the patient.There was no allegation of device failure.The device has not been returned to the manufacturer.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18670964
• MDR Text Key: 334921873
• Report Number: 2518422-2024-06273
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Operator: Health Professional
• Device Model Number: CN1111169
• Device Catalogue Number: CN1111169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2020
• 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 Outcome(s): Death