MAUDE Adverse Event Report: PHILLIPS RESPIRONICS NON - INVASIVE VENTILATOR

Model Number V 60

Device Problem Device Alarm System (1012)

Patient Problems Chest Pain (1776); Low Oxygen Saturation (2477); ST Segment Depression (2487)

Event Date 11/20/2016

Event Type  malfunction  

Event Description

While on non-invasive ventilator, nurse noticed pt was struggling to breathe.Respiratory therapist came to room.Two alarms were seen: "inline pressure low" and "proximal pressure low." pt's oxygenation level dropped into the 40s.Pt was placed on a non-rebreather mask.Corrections were double checked but nothing appeared wrong with equipment.New equipment obtained.Pt did experience chest pain and his telemetry monitoring showed st depression.He needed one dose of nitroglycerin.He returned to baseline functioning.

• Brand Name: NON - INVASIVE VENTILATOR
• Type of Device: NON - INVASIVE VENTILATOR
• Manufacturer (Section D): PHILLIPS RESPIRONICS; carlsbad CA 92011
• MDR Report Key: 6128663
• MDR Text Key: 61033307
• Report Number: MW5066337
• Device Sequence Number: 1
• Product Code: MNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V 60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR