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

Model Number DSX500S11F

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Scratched Material (3020)

Patient Problems Unspecified Respiratory Problem (4464); Localized Skin Lesion (4542)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

Filed a claim in (b)(6) of 2021 with philips respironics due to their recall of their dreamstation cpap.Due to a bone scan for prostate cancer, a lesion was found in my sinus.I called philips multiple times over the last 16 months explaining my concern over the philips recall due to my health condition.I was told multiple times that my claim was not "matched" to a dme record so they could not process my claim.I finally received a used refurbished dreamstation 1 blower half of a cpap today.The blower half was in a cardboard box with scratches indicating it was definitely used.It was manufactured 8/25/2018.I do not feel comfortable using a machine which was previously use by someone else.There is no indications that the machine was even sanitized.Philips response to this recall has been totally unacceptable.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 15499211
• MDR Text Key: 300897748
• Report Number: MW5112312
• 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: 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/29/2018
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; COQ 10; FISH OIL; IRON SUPPLEMENT; MULTIVITAMIN
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White