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

Model Number 582059

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)

Patient Problems Low Oxygen Saturation (2477); Respiratory Failure (2484)

Event Date 02/01/2018

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch, report number (b)(4), alleging a bipap vision had a ventilator inoperative condition.The patient's blood oxygen level decreased and the patient was manually ventilated.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap vision allegedly having a ventilator inoperative condition.The patient's blood oxygen level decreased and the patient was manually ventilated.The patient cardiac arrested shortly after the event and the family requested to have comfort measures during cardiopulmonary resuscitation.The patient expired.The device was evaluated by a third party service center.The device was tested and was found to operate and alarm to design specifications.Product labeling states,"the bipap vision ventilator is an assist ventilator and is intended to augment the ventilation of a spontaneously breathing patient.It is not intended to provide the total ventilatory requirements of the patient.The device is contraindicated on patients wih severe respiratory failure without a spontaneous respiratory drive and that is incapable of maintaining life-sustaining ventilation in the event of a brief circuit disconnection or loss of therapy.".

• Brand Name: BIPAP VISION
• 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: 7690941
• MDR Text Key: 114075268
• Report Number: 2518422-2018-01654
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 582059
• Device Catalogue Number: 582059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2005
• 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): Required Intervention
• Patient Age: 64 YR