FDA Adverse Event Injury Summary report: N

RESPLABS CPAP HOSE PERFECT FIT REPLACEMENT TUBING FOR ALL CPAP MACHINES 6FT STAN

MDR report key: 19585545 · Received June 20, 2024

Report

Report Number
MW5156463
Event Type
Injury
Date Received
June 20, 2024
Date of Event
June 10, 2024
Report Date
June 17, 2024
Manufacturer
RESPLABS MEDICAL USA INC.
Product Code
BYX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I'VE BEEN A CONTINUOUS POSITIVE AIRWAY PRESSURE USER FOR TEN YEARS AND NEVER HAD A PROBLEM WHEN PURCHASING ORIGINAL EQUIPMENT MANUFACTURER PRODUCTS. I AM A NURSE PRACTITIONER. HOWEVER, I PURCHASED FROM A THIRD-PARTY COMPANY A SET OF THREE CONTINUOUS POSITIVE AIRWAY PRESSURE HOSE ON AMAZON.COM FROM THE RESPLABS MEDICAL INC. STORE. ALL THREE HOSES COLLAPSED IN A SHORT AMOUNT OF TIME PREVENTING ME FROM BREATHING ADEQUATELY. THIS COLLAPSE OF THE TUBING OBSTRUCTED MY BREATHING WHILE ASLEEP AND CAUSED GREAT HARM. I HAD SYMPTOMS FOR MONTHS OF INCREASED FATIGUE, BRAIN-FOG, DREAMS OF SUFFOCATING, WAKING UP SHORT OF BREATH, GAGGING AND COUGHING BUT NOT REALIZING IT WAS THE HOSE UNTIL I ACTUALLY SAW IT HAPPEN. I DECIDED TO OBSERVE THE HOSE MECHANISM IN ACTION DURING THE DAYTIME. MY CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE ALGORITHM WAS WARNING ME THAT MY CONTINUOUS POSITIVE AIRWAY PRESSURE SUPPLIES NEEDED TO BE CHANGED. I'M LUCKY I HAVE A MEDICAL BACKGROUND AND DISCOVERED THE PROBLEM BEFORE LONG TERM PERMANENT HARM COULD OCCUR. I BELIEVE MOST PEOPLE WILL NOT REALIZE THERE IS A MANUFACTURING DEFECT UNTIL IT IS TOO LATE OR A SERIOUS EVENT OCCURS. THIS PROBLEM SHOULD NEVER OCCUR WITH NEW OR OLD CONTINUOUS POSITIVE AIRWAY PRESSURE HOSE. I NOTIFIED THE COMPANY BUT HAVE NOT HEARD BACK YET. THE HOSE IS NAMED "RESPLABS CONTINUOUS POSITIVE AIRWAY PRESSURE HOSE PERFECT FIT REPLACEMENT TUBING FOR ALL CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINES 6FT STANDARD 22MM, BLACK-OUT, (PACK OF THREE)". I REALLY THINK A RECALL ON THE PRODUCT IS NECESSARY AS IT SAYS THEY HAVE SOLD OVER (B)(4) OF THEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
208486 RESPLABS CPAP HOSE PERFECT FIT REPLACEMENT TUBING FOR ALL CPAP MACHINES 6FT STAN TUBING, PRESSURE AND ACCESSORIES BYX RESPLABS MEDICAL USA INC. RM-BLKTUB-PRAU

Patients

Seq Age Sex Outcome Treatment
1 54 YR Female Life Threatening| O AMBIEN.| CEVIMELINE.| CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE.| IRON.| METOPROLOL.| MICARDIS.| PAXIL.| PREDNISONE.| PRILOSEC.| REXULTI.| VITAMIN B.| VITAMIN D.