MAUDE Adverse Event Report: RESMED CORP. RX SILICONE MASK FOR CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Use of Device Problem (1670); Gas/Air Leak (2946); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Inflammation (1932); Unspecified Respiratory Problem (4464)

Event Date 06/01/2022

Event Type  Injury  

Event Description

New cpap patient, received a silicone mask that did not seal due to facial hair.The tech thought it wouldn't really work but kindly gave it to the patient anyway so he would have something to use while waiting for the correct mask (foam) which was only supposed to take 3 days to arrive (it took over two weeks), and also so he could try it just in case it did work.The poor seal caused the pressurized airflow to be constantly ramped up, and the patient did not realize this was dangerous.He began complaining of sinus irritation and lung irritation.His pain in the heart area of his lungs became very severe and he had to go the emergency room on (b)(6) 2022.Labs, ekg, xray were fine, he was sent home with possible muscle strain.He followed up with cardiologist on (b)(6) 2022 who diagnosed inflammation and prescribed medication which he unable to begin taking until (b)(6) 2022.He received and had a chance to start wearing the foam mask before he started the new medication, and felt somewhat better.The medication did the rest.I cannot supply the labeling information from the silicone mask because the packaging was not given to us.I can supply the receipt for services, and a picture of the mask.Fda safety report id # (b)(4).

• Brand Name: RX SILICONE MASK FOR CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 14695738
• MDR Text Key: 294173265
• Report Number: MW5110327
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/10/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; CHOLCHICINE (TAKING FOR 2 WEEKS ONLY POST EVENT); LASIX ; LISINOPRIL; NEXIUM; PLAVIX; XERALTO
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White