MAUDE Adverse Event Report: RESPIRONICS, INC. PHÖNIX 3I A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	HL564S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A phönix 3i a-flex device was returned to a service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of patient injury or harm.No medical intervention was required for the patient.During the evaluation of the device, the service center visually inspected the device and found evidence of visible foam particles.The device was scrapped.
Additional Manufacturer Narrative
Philips respironics had previously reported on this phönix 3i a-flex, sys one, 60 srs device, but we are not the legal manufacturer of this device.We are the distributor.Philips respironics will notify h&l (lowenstein medical) since they hold the rights to the ce mark and the reporting responsibility decisions.

• Brand Name: PHÖNIX 3I A-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19488555
• Report Number: 2518422-2024-34596
• Device Sequence Number: 8538139
• Product Code: BZD
• UDI-Device Identifier: 00606959030732
• UDI-Public: 00606959030732
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: HL564S
• Device Catalogue Number: HL564S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown