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

Model Number	AUX500T15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an end user is investigating if a continuous positive airway pressure (cpap) device has caused a lump in her throat related to the sound abatement foam.The device has yet to be returned to the manufacturer for evaluation.A final report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received the devices for evaluation.The manufacturer found no evidence of thermal, physical damage or odor.The manufacturer operated the dreamstation and humidifier with a bacteria filter in line during testing.There was no evidence of any black debris on the bacteria filter, nor any evidence of foam material or odors being emitted during testing.The internal inspection of the devices found no evidence of loose sound abatement foam or odor in the blower motor/box or in the airpath of the device.The manufacturer previously reported an issue related to sound abatement foam.This action was reported to fda per 21 crf part 806.The device will be corrected per res 88058.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 12069909
• Report Number: 2518422-2021-01823
• Device Sequence Number: 16997226
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Other