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 Codes	Arrhythmia (1721); Dyspnea (1816); Headache (1880); Dizziness (2194)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing headaches, dizziness, palpitations and shortness of breath for about 10 years.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15031344
• Report Number: 2518422-2022-60181
• Device Sequence Number: 6214681
• Product Code: BZD
• UDI-Device Identifier: 00606959030732
• UDI-Public: 00606959030732
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: Lay User/Patient
• 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: 11/25/2021
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2015
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown