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

Model Number DSX500T11

Device Problem Degraded (1153)

Patient Problems Erythema (1840); Rash (2033); Skin Discoloration (2074); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)

Event Date 08/26/2021

Event Type  malfunction  

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 patient alleges the mask broke out his skin causing it to become dry and red and that he also broke out around the eye area while using the device.Patient states he received multiple treatments from his doctor.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.Three attempts to gather additional information from the patient for further investigation were unsuccessful.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information 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 patient alleges the mask broke out his skin causing it to become dry and red and that he also broke out around the eye area while using the device.Patient states he received multiple treatments from his doctor.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.The evaluation method, results and conclusion codes were incorrectly coded and is corrected in this report.The b5 statement on the initial report was incorrectly documented with both statements: three attempts to gather additional information from the patient for further investigation were unsuccessful and the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Maxed attempts were confirmed on (b)(6) 2023.The conclusion of the investigation is corrected in this report.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

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 patient alleges the mask broke out his skin causing it to become dry and red and that he also broke out around the eye area while using the device.Patient states he received multiple treatments from his doctor.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.On the previously submitted report, the "type of reportable event" and "outcomes attributed to ae" in section b.Were both reported incorrectly.It is corrected on this report.

• 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: 17050036
• MDR Text Key: 316402597
• Report Number: 2518422-2023-12725
• 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,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: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/21/2023; 06/21/2023
• Supplement Dates FDA Received: 06/20/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other