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

Model Number	DEX400S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and causing a heart attack.The patient did receive medical intervention requiring hospitalization.This issue was reported to the fda per 21 cfr 806.The device will be corrected per (b)(4).
Additional Manufacturer Narrative
Additional information was received on oct 11, 2024 and section h11 should be reported as: the manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and causing a heart attack.The patient did receive medical intervention requiring hospitalization.The device was returned to the third-party service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed.There were two errors found.The third-party service center concludes that they could not confirm the customer's allegation and there was no visible foam degradation.The device was scrapped.Sections d8, d9, h2, h3, h6 has been updated in this report.
Additional Manufacturer Narrative
This case was previously reported in error in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.This was incorrect and following further review of the complaint information and investigation this case is should not be considered as part of the voluntary recall.The manufacturer received information alleging that the dreamstation device was set to 12 mbar during customer use, however the output of the device was stated to only deliver at 8-9mbar.The patient was alleged to suffer a heart attack, occurrence date and time were not provided, and required medical intervention.Limited information has been provided.No additional information is available at this time.In the initial report, sections h7 and h9 was captured incorrectly and it should be blank.

• Brand Name: DREAMSTATION CPAP PRO, GER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12541051
• Report Number: 2518422-2021-04458
• Device Sequence Number: 4031578
• Product Code: BZD
• UDI-Device Identifier: 00606959024083
• UDI-Public: 00606959024083
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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: DEX400S13
• Device Catalogue Number: DEX400S13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/11/2024; Not provided
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/05/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Other
• Patient Sex: Unknown