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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged rashes on face, two dark spots on face which is getting bigger.There was no report of serious or permanent patient harm or injury.The device was returned but yet not evaluated.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was previously 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.Patient alleged rashes on face, two dark spots on face which is getting bigger.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer and found evidence of liquid ingress and an unknown dust contaminant, an unknown contaminant and keratin-like substance in the blower, blower box, inside the filter area of the blower box, top enclosure, iso port of the rear panel, front panel, and the blower seal.The humidifier was returned to the manufacturer¿s product investigation laboratory for evaluation.The manufacturer found evidence of mineral deposits and an unknown contaminant in the water tank, bottom enclosure, dry box flip lid, water tank lift tray, bottom enclosure, dry box seal, and dry box.The manufacturer found evidence of sound abatement foam degradation /breakdown.The manufacturer applied power to the device and verified device powers on and provides airflow.The manufacturer concludes the contaminates found were consistent with liquid ingress an unknown contaminate, dust and keratin.The manufacturer confirmed there was evidence of sound abatement foam degradation/breakdown.Humidifier dsxhcp (sn- (b)(6)).

• 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: 16075106
• MDR Text Key: 306429124
• Report Number: 2518422-2022-103569
• 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

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• 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