MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS DSX500HIIC; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500HIIC

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Fever (1858); Muscle Weakness (1967); Pain (1994); Burning Sensation (2146); Sore Throat (2396); Diaphoresis (2452)

Event Date 02/08/2020

Event Type  Injury  

Event Description

I used the respironics dsx500hiic and dreamstation auto cpap (b)(4) w/ respironics dsxh dreamstation humidifier (b)(4) beginning on (b)(6) 2020.I purchased a purify o3 cpap/bipap sanitizer ventilation disinfector model #190-6000 purify o3 sanitizer , xd100 sn# (b)(4) all medical equipment was made in china.I am not sure of the exact date but began having deep-breathing difficulties on a wednesday night.It was hard to breath, painful, and i was exhausted.I discussed this with the tideway aquatic therapy supervisor on thursday.I was advised to get a chest x-ray for pleurisy or pneumonia.I held off, but on saturday i woke up worse.Taking deep breaths was painful, burning, and i developed a fever with heavy sweating and was weak.My roommate took me to (b)(6).Dr (b)(6) diagnosed pneumonia but said she had not seen the light-colored collection of fluid in lungs before.I was given a prescription for cephalexin 500 mg caps lupi and told to not skip a dose.She also told me to schedule a follow-up with dr (b)(6) (pcp) in two weeks.The primary pain was burning in my throat and nose with breathing difficult.It was shortly after that cpap machines were recalled but nothing was said about the purify o3 device.I have gone without a cpap machine all this time and need to get one asap.Thank you for the opportunity to share this medical information.If further information is necessary, please let me know.(b)(6).I have a complete report with data for many categories.I do not know how to give: titration summary, pes summary, oxygen saturation summary, ecg summary, heartate details, rhythym details, arousal summary, or limb movement summary due to the detail in each category.There was also a page with hypopnea criteria, summary statements, parameters, and scoring information.The study consisted of the parameters and overnight recordings of continuous ekg waveform, continuous airflow assessment, monitoring of respiratory effort, continuous overnight oximetry with a sampling rate of 10 samples / second, and video recording.(b)(4).Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS DSX500HIIC
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 15605965
• MDR Text Key: 301944126
• Report Number: MW5112625
• Device Sequence Number: 2
• Product Code: LRJ
• 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
• Type of Report: Initial
• Report Date: 10/11/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500HIIC
• Patient Sequence Number: 1
• Treatment: ANTACID CONTROL; ANTI-DEPRESSANT; APPLE CIDAR VINEGAR; ARMODAFINIL TAB 50 MG; ATORVASTATIN TAB 20 MG; BENEFIBER WAFERS; CEPHALEXIN 500 MG X4 PRE-MED; CLONAZEPAM TAB 0.5 MG 2X/DAY (STOPPED UNTIL I CAN GET BACK ON CPAP, HAVE CORRECTIVE SURGERY, OR INSPIRE PROGRAM); CLOPIDOGREL BISULFATE TAB 75 MG; DIURETIC; FISH OIL; LIPITOR; LOW-DOSE ASPIRIN; MECLIZINE HCL TAB 12.5 MG 1 TAB 3X / DAY AS NEEDED; NUVIGIL 50 MG; OMEPRAZOLE DR CAPSULES 20 MG X 3; OZEMPIC 1.5 INJECTION; PRE-MED BEFORE DENTAL AND ANY SURGERIES. ; TAKE PLAVIX; TRAZODONE HCI ZYDU 100 MG; TRIAMTERENE HCTZ CAP 37.5/25 MG; TURMERIC; VITAMIN B-D-C
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White