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

Patient Problems Dyspnea (1816); Fall (1848); Scar Tissue (2060); Convulsion/Seizure (4406); Syncope/Fainting (4411); Cough (4457); Nodule (4551)

Event Date 08/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2023 ct scan with omnipaque (shortness of breath continues "several scattered ground glass changes in bilateral pulmonary lobes.Nodules measuring up to 4mm, some up to 1.1 cm.More modular appearance of previously noted scarring in the periphery of right upper lobe." 2024 (breathing issues continue even using cpap and working out 4-5 days per week) (b)(6) 2024 ct scan without contrast (shortness of breath) "still clinical concern, several 2-4 mm nodules hazy density." (b)(6) 2024 (b)(6) says stress test is ok (b)(6) 2024 (b)(6) orders another ct scan and wants him to do a heart monitor.We've contacted all of (b)(6) doctors again as he has now lost consciousness 6 times just this year.If he laughs or coughs, he can't take a breath in and completely passes out.Once in the kitchen, he went all the way down from standing and hit the floor very hard, and again on the back porch to the concrete floor.Another while in bed, started coughing and sat up to breathe and fell off the bed into the wall.The other times, thankfully, he's been sitting down.When he loses consciousness, he kind of has a little seizure activity with his hands/arms before we can wake him up.We have stopped him from driving, just in case he starts to cough.He says he definitely feels something in his lungs that's making him cough.Ct scan scheduled finally for 4/8 and we're waiting for insurance to approve his heart monitor.This is definitely getting worse daily.(b)(6) 2020 respshop (order (b)(4) purchase received of dream machine.Used nightly 12/18/2020 through 8/2021, until recall notice received 8/15/2021.Confirmation of philips device registration is 20211081701973923 on 8/17/2021.8/15/2021 respshop confirms recall registration (confirm # 67492) machine serial number (b)(6).

• Brand Name: PHILIPS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 19088712
• MDR Text Key: 340100967
• Report Number: MW5153727
• 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: 04/07/2024

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: 04/10/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White