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

Model Number DSX500S11F

Device Problems Use of Incorrect Control/Treatment Settings (1126); Nonstandard Device (1420)

Patient Problem Breast Cancer (1759)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Philips sent me a replacement dreamstation device due to the recall.Had the machine to malfunction by going into max pressure 3 times within a 2 week period.Reported it to philips but it still has not been replaced as of (b)(6) 2023 and i am going through chemo treatments at this time for stage 2 her2 breast cancer.

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16305370
• MDR Text Key: 308959020
• Report Number: MW5114703
• 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
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2019
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: (PREMED PEPCID, DECADRON, BENADRYL 50MG); ANASTROZOLE 1 MG DAILY STARTED ; ASA 81MG QOD ; CALTRATE+D3 600MG 1 TAB BID ; CBD OIL PRN FOR SLEEP ; CENTUM SILVER 1 TAB DAILY ; D3 125MCG 1 TABS DAILY; GABAPENTIN 300MG QD ; GARLIC 1000MG DAILY ; HERCEPTIN Q 3WKS X18 DOSES ; KRILL OIL 1000MG 2 TABS DAILY ; LIDOCAINE CREAM 1 HR BEFORE PORT ACCESS ; MELATONIN; MOTRIN PM 1-2 TABS PRN FOR SLEEP ; MOVE FREE ULTRA 1 TAB DAILY ; SULFA; TAXOL Q WK X 12 3/21/2022 FINISHED 6/6/2022 ; TRAZODONE; TYLENOL OR IBUPROFEN PRN ; TYLENOL PM 1-2 TABS PRN FOR SLEEP ; XANAX 0.5MG 1/2/ TO 1 TAB DAILY PRN ANXIETY ; ZINC 50MG DAILY ; ZOFRAN 8MG Q8 HRS PRN NAUSEA
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White