MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUMID/HT, AUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AUX500T15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a blood clot in their lung.The patient did receive medical intervention in the form of a doctor's assessment and a prescribed blood thinner medication.The manufacturer is attempting to have the device returned to its product investigation lab.The investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: d4 unique identifier (udi) number: previously reported as (b)(4) ; updated to (b)(4).E1 initial reporter contact (name) & address.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as : 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 a cpap device's sound abatement foam.The patient has alleged to develop a blood clot in their lung.The patient did receive medical intervention in the form of a doctor's assessment and a prescribed blood thinner medication.The reported event of blood clot in their lung and its reported severity was reviewed by the manufacturer's clinical expert.This event is assessed as not related to the device in this case.Based on the information available, the manufacturer concludes no further action is necessary.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 filled.Section b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect-impact code, type of investigation, investigation findings and investigation conclusions have been updated.
Additional Manufacturer Narrative
Section g1 was missed to capture in the final follow-up report (follow-up 2), which was updated in this report.
Additional Manufacturer Narrative
Additional information was received on november 12, 2024 and section h11 should be reported as: 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 alleged to develop a blood clot in their lung.The patient did receive medical intervention in the form of a doctor's assessment and a prescribed blood thinner medication.The reported event of blood clot in their lung related to cpap device's sound abatement foam.Sections b1, b2, h1 and h6 have been corrected in this report as follows: section b1 was corrected for both adverse events and product problem (only the product problem was checked in the previous mdr.) section b2 was corrected to other serious or important medical events.(previously, it was blank.) section h1 was changed from malfunction to serious injury.Section h6 health effects - clinical codes and health effects - impact code was corrected.

• Brand Name: DREAMSTATION AUTO CPAP W/HUMID/HT, AUS
• 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; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12091806
• Report Number: 2518422-2021-01995
• Device Sequence Number: 14480845
• Product Code: BZD
• UDI-Device Identifier: 00606959026018
• UDI-Public: 00606959026018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/20/2024

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: AUX500T15
• Device Catalogue Number: AUX500T15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/10/2023; 06/07/2023; Not provided
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/15/2021; 04/25/2023; 06/07/2023; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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
• Patient Sex: Female