MAUDE Adverse Event Report: RESPORINOC INC DREAMSTATION AUTO CPAP, ND; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	NDX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pharyngitis (2367); Sore Throat (2396)
Date of Event	08/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused a sore throat with mucous and inflammation.The patient did receive medical intervention resulting in prescribed medications.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.Section b2 has been corrected to reflect serious injury only and death was reported in error.Section h1 correctly reflects serious injury.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
Additional information was received on nov 07, 2024 and section h10 should be reported as: the manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused a sore throat with mucous and inflammation.The patient did receive medical intervention resulting in prescribed medications.There was no report of serious patient harm or injury.Section b1 was corrected for product problem.(both adverse event and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 was corrected and updated.

• Brand Name: DREAMSTATION AUTO CPAP, ND
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPORINOC INC; 101 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPORINICS, INC; 1001 murry ridge lane; murrysville,pa PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittisburgh,pa, PA 15206 ; 7243512041
• MDR Report Key: 12599641
• Report Number: 2518422-2021-04933
• Device Sequence Number: 4185698
• Product Code: BZD
• UDI-Device Identifier: 00606959027206
• UDI-Public: 00606959027206
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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: NDX500S15
• Device Catalogue Number: NDX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 04/19/2022; Not provided
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 04/19/2022; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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: Required Intervention; Other; Death
• Patient Sex: Unknown