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

Model Number 582059

Device Problems Mechanical Problem (1384); Failure to Read Input Signal (1581)

Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 11/01/2017

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch, report number (b)(4), that alleges a bipap vision fio2 control knob was unable to increase the fio2.The patient was transferred to the icu and was intubated and placed on a ventilator.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 fio2 control knob allegedly would not increase the fio2.The patient had low blood oxygen levels and had increased work of breathing.The patient was transferred to the icu and was intubated and placed on a ventilator.The reporter of the event can not locate the device.The device is not available at this time for further investigation.Product labeling states, "the bipap vision 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.".

• 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: 7690948
• MDR Text Key: 114075110
• Report Number: 2518422-2018-01655
• 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: 08/14/2018
• Supplement Dates FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2007
• 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 Age: 60 YR