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

Device Problems Material Erosion (1214); Nonstandard Device (1420); Particulates (1451)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908)

Event Date 04/11/2022

Event Type  Injury  

Event Description

In 2021 (b)(6) doctor informed him that his ((b)(6) provided) cpap (philips dream station) was recalled and that supply chain issues delayed replacement.He was told to continue using it until a replacement came.On (b)(6) 2022, we read an fda update on the recall, noting that deteriorating insulation could be expelled, producing black specks and that, if this happened, use of the cpap should be discontinued and dr.And supplier notified.Warren had recently noticed black specks on his pillow, sheets, and the carpet by the bed and discontinued use of the cpap.We phoned the office of the dr.(b)(6) and the supplier (respiratory +) both of whom said there was nothing to be done other than waiting for a replacement.Since (b)(6), (b)(6) blood pressure readings and pulse have been higher than previous readings and normal guidelines.We contacted the provider and the dr again and were told again that there was nothing to do but wait.Philips indicates replacement shortage could continue through december, 2022.We have heard from one person that (b)(6) requires suppliers to provide loaners but are unsure how to verify this or how to proceed.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS INC.
• MDR Report Key: 14408400
• MDR Text Key: 291835944
• Report Number: MW5109708
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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
• Patient Sequence Number: 1
• Treatment: 1 ALEVE OR 1ADVIL ; ACETAMINOPHEN; CALCIUM; DAILY - ATORVASTATIN 10 MG; DAILY - MULTIVITAMIN; DULOXETINE HCL 30 MG; FISH OIL; METOPROLOL 25 MG; MSM AS NEEDED ; PRIOR TO DENTAL VISITS - AMOXICILLIN (4X500 MG.); TADALAFIL 5 MG; VITAMIN C, D
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male