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

Model Number FRX500S14

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Fatigue (1849); Itching Sensation (1943); Dizziness (2194); Swollen Lymph Nodes/Glands (4432); Cough (4457); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 03/24/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused red patches on the face with pustules and pimples, itching and burning, pustules on the scalp, adenopathy, fatigue, dizziness, shortness of breath and cough.The patient did receive medical intervention and reported to have seen a physician and was prescribed corticoids, antifungals and antibiotics.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 a cpap device's sound abatement foam allegedly became degraded and caused red patches on the face with pustules and pimples, itching and burning, pustules on the scalp, adenopathy, fatigue, dizziness, shortness of breath and cough.The patient did receive medical intervention and reported to have seen a physician and was prescribed corticoids, antifungals and antibiotics.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The manufacturer performed an external visual inspection of the device.The manufacturer found evidence of contaminants on the outside of the device and in the inlet filter area, sd card area and on the humidifier latch ledge.The device was inspected internally and the manufacturer found evidence of 8 different types of contaminants which 4 were found in the airpath.The contaminatnts are consistently with being from an external source.The manufacturer found no evidence of sound abatement foam.

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 manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and caused red patches on the face with pustules and pimples, itching and burning, pustules on the scalp, adenopathy, fatigue, dizziness, shortness of breath and cough.These events were reviewed by the pms clinical expert and were assessed as unrelated to the device.

• Brand Name: DREAMSTATION AUTO
• 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: 14188793
• MDR Text Key: 289896258
• Report Number: 2518422-2022-14320
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

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 Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 06/08/2023
• Supplement Dates FDA Received: 08/25/2022; 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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; Other