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

Model Number NDX500S15

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device has not been returned to the manufacturer.

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 cpap device's sound abatement foam.The patient alleged having chest pain, chest pressure, irritation in the abdomen and abdominal cavities.In addition, the patient has taken 2 pantoprazole daily and did a biopsy of duodenal mucous membranes, gastric mucosa showing chronic inflammation.The device was returned to third party service center but not yet evaluated.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

In the previous report, box b and box h were incorrect, box b and box h have been updated/corrected in this report.

Manufacturer Narrative

The manufacturer previously submitted this complaint as a serious injury, but after pms review it was determined that there is no allegation of serious or permanent patient harm or injury.The manufacturer received additional information that the device was returned to a third party service center as of 10/16/2023.During device evaluation, dust/dirt was only observed in the device.There was no evidence of foam degradation.The device was scrapped.The device's downloaded event log was reviewed by the manufacturer and found e-130, e-200 and e-53 on the error log.

• 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: 18198395
• MDR Text Key: 328902685
• Report Number: 2518422-2023-31448
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup

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
• Device Operator: Lay User/Patient
• Device Model Number: NDX500S15
• Device Catalogue Number: NDX500S15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 11/23/2023
• Supplement Dates Manufacturer Received: 11/23/2023; 11/23/2023
• Supplement Dates FDA Received: 11/23/2023; 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2018
• 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