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

Model Number AUX500T15

Device Problem Degraded (1153)

Patient Problem Embolism/Embolus (4438)

Event Date 06/29/2021

Event Type  malfunction  

Event 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.

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.

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.

Manufacturer Narrative

Section g1 was missed to capture in the final follow-up report (follow-up 2), which was updated in this report.

• Brand Name: DREAMSTATION AUTO CPAP W/HUMID/HT, AUS
• 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: 12091806
• MDR Text Key: 259128257
• Report Number: 2518422-2021-01995
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959026018
• UDI-Public: 00606959026018
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AUX500T15
• Device Catalogue Number: AUX500T15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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): Required Intervention
• Patient Sex: Female