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

Model Number 582080

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Device Operational Issue (2914)

Patient Problem Coma (2417)

Event Date 12/01/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap vision did not alarm.The patient was intubated and placed on a ventilator.The patient reportedly is in a coma.The device has yet to be evaluated by the manufacturer's service center.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap vision allegedly did not alarm.The patient was intubated and placed on a ventilator.The patient reportedly is in a coma.The device was evaluated by the manufacturer's field service technician.The customer's complaint was not confirmed.The device was found to operate and alarm to design specifications.

• 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: 7109027
• MDR Text Key: 94538643
• Report Number: 2518422-2017-02855
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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: 582080
• Device Catalogue Number: 582080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2007
• 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 Outcome(s): Required Intervention