MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTOSV; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number FRX900S14

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Cancer (3262)

Event Date 04/06/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused prostate cancer.The patient did receive medical intervention and reported to have prostate surgery, radiation therapy and blood tests.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.This complaint has been reviewed and the following corrections have been made to reflect an " other serious or important medical events" in b(2).This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.

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 prostrate cancer related to a bipap device's sound abatement foam.The patient did receive medical intervention and reported to have prostate surgery, radiation therapy and blood tests in response to the reported event.Section b5 was incorrectly reported in the initial report.It should be reported as the manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused prostate cancer.The patient did receive medical intervention and reported to have prostate surgery, radiation therapy and blood tests.The device was returned to the manufacturer's service center for further evaluation.The internal and external aspects of the device was evaluated.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation, no foam particles inside the assembly and confirmed the presence of dust/dirt inside the device.The unit is scrapped.Section d5 corrected.Section h6 updated in this report.

• Brand Name: DREAMSTATION AUTOSV
• Type of Device: 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: 14223681
• MDR Text Key: 290573828
• Report Number: 2518422-2022-15508
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: FRX900S14
• Device Catalogue Number: FRX900S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 09/10/2023
• Supplement Dates FDA Received: 05/25/2022; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other