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

Model Number DSX700S11F

Device Problem Particulates (1451)

Patient Problems Aspiration/Inhalation (1725); Pain (1994); Cough (4457)

Event Type  Injury  

Event Description

Patient ("pt") reported white powder is and has been showing up in the filter of her philips respironics ("respironics") dreamstation bipap ("replacement bipap") that was sent to her directly by respironics to replace her recalled dreamstation bipap.Pt received her replacement bipap directly from respironics in (b)(6) 2021.The serial number of the replacement bipap is (b)(4).Pt's report was made to the dme company official on (b)(6) 2022.Pt reported white powder has appeared in the reusable filter and disposable filters of the replacement bipap since she began to use the replacement bipap.Pt states that white powder is in the filters currently in her replacement bipap.Pt stated that she has changed the disposable filter several times, but the problem is recurring.The white powder was visible in the respironics-brand filters that were sent to her by respironics in the box along with her replacement bipap, and the white powder has continued to be visible since that time in the filters that she has changed since that time.Pt reported that when using the replacement bipap, she sometime awakened in the night and hacked and coughed horrendously, which caused her stomach to hurt from coughing so hard.Pt stated this is a dry cough and nothing comes up.She noticed that the white powder may be causing the cough but is not sure.Pt stated that she does not have asthma or preexisting breathing conditions.Pt stated that she stopped using her replacement bipap approximately 2 weeks ago because of the white powder and effects thereof.Pt stated that once she stopped using the replacement bipap, she did not cough.Pt stated she does not use baby powder or other white powder in her home.Pt reported that her nephew also had a replacement machine (pap) from respironics, which had powder in it.Pt stated that her nephew sent that machine back to respironics pt presented to dme company office to have the replacement bipap checked out on (b)(6) 2022.This was the dme company's first day of notice of pt's report.Dme company official observed that white powder is indeed visible in the reusable filter and disposable filter in the replacement bipap.Dme company official also observed that white powder was of such high quantity that removal of both filters caused a visible amount of white powder to spill out onto the wooden desktop.Dme company official observed that some white powder was also visible in other parts of the equipment.Dme company official wrote out a progress note based on the pt's report, in the presence of the pt, and the pt signed and dated the progress note after reviewing it to confirm its factual accuracy.Pt reported back to the dme company later that same day, per request of the dme company official.At that time, the dme company official asked pt whether she observed any physical effects while using the replacement bipap with the white powder, and pt provided information in response thereto, which was memorialized in a progress report--supplemental.Pt signed and dated the progress report--supplemental after reviewing it to confirm its factual accuracy.Both the progress note and the progress note--supplemental were also signed and dated by the dme company official.Replacement bipap has been bagged and tagged with the pt's identification per protocol of the dme company's medicare accreditor.Replacement bipap will be returned by dme company to respironics on (b)(6) 2022, along with a copy of this completed medwatch voluntary report.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION BIPAP (RECERTIFIED DEVICE)
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14547412
• MDR Text Key: 293085724
• Report Number: MW5109970
• Device Sequence Number: 2
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX700S11F
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White