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

Model Number SYSTEM ONE AUTO DS560

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

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 02/02/2021

Event Type  Injury  

Event Description

My father was hospitalized on (b)(6) 2021 for pneumonia.During that time, his doctor suggested that i assess his home cpap machine.I brought his cpap unit to (b)(6) for assessment, and their findings stated, "foam particles were exiting when pressure was on.This unit cannot be repaired and is recommended for replacement." on (b)(6) 2021, my dad had received a recall notice on that unit.That notice stated, "pe-pur foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by user.These issues can result in serious injury which can be life threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment." because of these findings, my family and i were lead to believe this cpap machine was responsible for my dad's hospitalization.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP UNIT
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13358604
• MDR Text Key: 284535669
• Report Number: MW5106975
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SYSTEM ONE AUTO DS560
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Patient Sequence Number: 1
• Treatment: DULCOLAX SUPPOSITORY AS NEEDED.; EYE DROPS FOR GLAUCOMA; METAMUCIL CAPSULES DAILY
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian