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

Model Number 582059

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem Loss Of Pulse (2562)

Event Date 08/16/2015

Event Type  Injury  

Event Description

The manufacturer received a user facility report, reference number (b)(4), alleging a bipap vision was not ventilating and failed to alarm while in patient use.The patient became pulseless and cardiopulmonary resuscitation was administered.The patient was intubated and placed on a ventilator.The device has not returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

• Brand Name: BIPAP VISION
• 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: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5184779
• MDR Text Key: 29742143
• Report Number: 2518422-2015-03501
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2008
• 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: 50 YR