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); Headache (1880)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged difficulty breathing; device has service required message; headache.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058 i.

Manufacturer Narrative

The manufacturer was initially 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 reported an allegation of an issue related to a bipap device's sound abatement foam.The patient alleged difficulty breathing; device has service required message; headache.There was no allegation of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation, evidence of sound abatement foam were not observed in the base unit.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device.Observed evidence of water ingress in the blower box and inside of the blower, suggesting the use of non-distilled water in the humidifier water chamber.Observed evidence of water ingress on the p4 connector.The device's downloaded event log was reviewed by the manufacturer and found two erorrs.The manufacturer concludes can confirm the contamination found in the device enclosure suggests a source external to the device.Can confirm evidence of water ingress in the blower and blower box.Can confirm corrosion on the p4 connector due to water ingress.

• 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: 14086470
• MDR Text Key: 298612993
• Report Number: 2518422-2022-12953
• 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: 01/17/2024

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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