MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Tissue Breakdown (2681)

Event Date 09/22/2021

Event Type  Injury  

Event Description

I started to have sores in my nostrils first the right nostril and then the left.I had to stop using my machine for a week or so and then it got better.My shortness of breath has gotten worse.Didn't bother to have any test done since the nose issue cleared up by itself.Also, i just thought my pulmonary hypertension was getting worse.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12738109
• MDR Text Key: 280004920
• Report Number: MW5105076
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 136