FDA Adverse Event Injury Summary report: N

RESMED AIR 10

MDR report key: 13076994 · Received December 22, 2021

Report

Report Number
MW5106244
Event Type
Injury
Date Received
December 22, 2021
Date of Event
October 1, 2021
Report Date
December 20, 2021
Manufacturer
RESMED ASIA PTE. LTD.
Product Code
LRJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

COUGHING, NASAL, NAUSEA; I HAVE BEEN EXPERIENCING A CHRONIC COUGH AND COUGHING FITS WHEN USING MY CPAP (RESMED AIR 10) FOR AT LEAST A COUPLE OF MONTHS. AT FIRST, I DID NOT EQUATE IT TO USING THE CPAP. RECENTLY I HAVE BEEN EXPERIENCING NAUSEA WITHIN AN HOUR OR TWO OF USING THE CPAP. I HAVE BEEN USING THE SOCLEAN 2 CLEANER SINCE I PURCHASED IT ON (B)(6) 2018 FROM (B)(6). FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1964581 RESMED AIR 10 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) LRJ RESMED ASIA PTE. LTD. 37028 1129330
1964582 SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

Patients

Seq Age Sex Outcome Treatment
1 56 YR Male Other AMLODIPINE | DAILY MULTI VITAMIN | LISINOPRIL