MAUDE Adverse Event Report: RESPIRONICS RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK

Model Number 1007964

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pneumothorax (2012)

Event Date 04/25/2015

Event Type  Injury  

Event Description

Suddenly developed severe shortness of breath and chest pain on (b)(6) 2015 while using respironics comfortclassic medium cpap mask (product no.(b)(4), lot no.140408).Evaluated in emergency room (b)(6) 2015, and found to have right lung tension pneumothorax on chest x-ray.Immediately had right sided thoracostomy with placement of chest tube under vacuum and admitted to hospital.Chest tube was removed on (b)(6) 2015 and discharged from hospital on (b)(6) 2015.After discharge from hospital, cpap mask was closely examined and was found to have an almost completely occluded exhalation port.This was confirmed by being unable to slip a piece of paper into the exhalation port.Comparison to a different, old respironics comfortclassic medium cpap mask using the same piece of paper showed that the old mask had a patent exhalation port, unlike the mask that is suspected to have caused the problem.

• Brand Name: RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK
• Type of Device: RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 4758687
• MDR Text Key: 16464724
• Report Number: MW5042567
• Device Sequence Number: 1
• Product Code: NHJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1007964
• Device Catalogue Number: 1007964
• Device Lot Number: 140408
• Patient Sequence Number: 1
• Treatment: RTC MEDS: CPAP AND TUBING WITH RESPIRONICS; COMFORTCLASSIC MEDIUM CPAP MASK.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 109