MAUDE Adverse Event Report: PHILIPS/RESPIRONICS INC. SYSTEM ONE BIPAP MACHINE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number SYSTEM ONE

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Dear fda staff: i am part of the philips respironics cpap and bi-level pap medical device recall effort.I owned a respironics system one bipap machine.Philips notified me in (b)(6) 2021 to immediately stop using the machine due to potential issues with the gaskets and seals degrading.My confirmation code number with philips is (b)(4).My system one serial number is s/n: (b)(4) since my machine is no longer serviceable by philips, i was informed in october 2022 that the most i would see would be a check in the amount of (b)(6).I was then instructed to ship the medical device back to philips.The medical device was shipped via fedex with tracking number (b)(4) on 10/31/2022.The medical device was received by philips on 11/04/2022.On (b)(6) 2023 i contacted philips regarding the (b)(6) check and asked when i should expect it to be sent to me.The customer rep indicated i should receive a phone call from philips.I never received a return phone call as to the status of this issue.As of 1/24/2023 i have not received any follow-up information as to when philips intends to send out the settlement check.I would like to know when philips intends to send the settlement check out for this medical device recall?.

• Brand Name: SYSTEM ONE BIPAP MACHINE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 16253985
• MDR Text Key: 308443898
• Report Number: MW5114530
• Device Sequence Number: 1
• Product Code: MNS
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYSTEM ONE
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White