MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

Section b5 was incomplete in previous report and to be reported as: 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 visualization of black particles in tubing/chamber related to a cpap device's sound abatement foam.Patient alleged having difficulty breathing/short of breath.No medical intervention was reported.The device was returned to the manufacturer's quality product investigation laboratory for investigation.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.Error logs were reviewed and 1 instance of continue error e-193 (err_usb_host_no_device) was reported in the error log.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device.Investigation observed evidence of water ingress in the blower box and inside of the blower, suggesting the use of no distilled water in the humidifier water chamber.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed investigation can confirm the presence of dust/dirt contamination in the airpath, could confirm the presence of water ingress in the blower box and blower and found no evidence of sound abatement foam degradation or breakdown.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13112930
• MDR Text Key: 283243438
• Report Number: 2518422-2021-08856
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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