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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Eye Pain (4467)

Event Date 10/05/2022

Event Type  Injury  

Event Description

Am not sure on my dates sorry as i had to stop using the machine because of my problem, i noticed after not long using the machine that my eyes were becoming irritable for quite a while so i would have a night without using crap, my eyes were getting very itchy and even began to ache, i put up with this for a few months but they began to water and by morning looked like i had been crying.I became worried so went to the optician who told me my eyes were so dried out from the machine they treated me with drops, since this happened it feels like i have been left with quite a lazy eye so i have not used the machine anymore, i went to get my machine replaced yesterday but i refused it as so afraid this might happen to me again.I had my glasses renewed as my sight had deteriorated but still not fixed the feeling in my eye, i would rather manage my sleep myself than use a machine again.Fda safety report id# (b)(4).

• Brand Name: CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15673652
• MDR Text Key: 302520250
• Report Number: MW5112849
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White