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	Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have kidney cancer.The medical intervention that the patient received in response to the event is currently unknown.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam and became degraded and caused the patient to have kidney cancer.The medical intervention that the patient received in response to the event is currently unknown.Section g3 was corrected to reflect the bad when new information was received.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam and became degraded and caused the patient to have kidney cancer.The medical intervention that the patient received in response to the event is currently unknown.Despite multiple attempts on 03/25/2022, 04/05/2022, 04/20/2022, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section h6 updated in this report.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging an issue related to sound abatement foam.The reported kidney cancer, severe palpitation and headache were not related to the device because those allegations were identified as past medical history.There was no report of serious or permanent patient harm or injury.The device has not yet returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.  section(s) b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section b7 updated with past medical history.Section h1 has changed to reflect a malfunction.Section h6 health effect- clinical code and impact code has been updated.

• 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: 13509909
• Report Number: 2518422-2022-03916
• Device Sequence Number: 14463073
• Product Code: BZD
• UDI-Device Identifier: 00606959030732
• UDI-Public: 00606959030732
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2023

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
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 04/20/2022; 10/12/2023
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 08/09/2022; 08/10/2022; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown