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

Model Number DSX500T11C

Device Problems Degraded (1153); Noise, Audible (3273)

Patient Problem Chest Pain (1776)

Event Date 06/15/2021

Event Type  Injury  

Event Description

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 received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged the device is making noise like the horn and causing her to have sharp pain in her chest, has noticed when she is on the machine she is having more pain and she has been having sharp chest pains after usage.Also stated had to change tubing because it was bothering her.Medical intervention happened, at emergency room of hospital patient stated that she was instructed to take bayer aspirin for the pain.No serious patient harm or injury reported.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : not returned to manufacturer.

Manufacturer Narrative

Previously, the manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged the device is making noise like the horn and causing her to have sharp pain in her chest, has noticed when she is on the machine she is having more pain and she has been having sharp chest pains after usage.Also stated had to change tubing because it was bothering her.Medical intervention happened, at emergency room of hospital patient stated that she was instructed to take bayer aspirin for the pain.No serious patient harm or injury reported.Now, the manufacturer alleging that the allegation is serious injury and submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Corrected section b1 from product problem to both.B2 selected as other.Section selected as serious injury, h6 has been updated/corrected.In addition, appropriate code updated/ corrected.

• Brand Name: DREAMSTATION AUTO CPAP
• 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 15208 ; 4125423300
• MDR Report Key: 18140019
• MDR Text Key: 328167057
• Report Number: 2518422-2023-30214
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female