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

Model Number DSX700H11

Device Problems Degraded (1153); Fire (1245)

Patient Problems Hemoptysis (1887); Sore Throat (2396); Respiratory Tract Infection (2420)

Event Date 10/10/2022

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 manufacturer received information alleging an issue related to a (cpap/bipap) device's sound abatement foam.The patient has alleged particle in device, nasal/throat irritation or soreness, coughing up blood.There was no report of patient harm or injury.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, and mechanical ventilator devices.The manufacturer received information alleging particles in device, coughing up blood, and nasal/throat irritation or soreness.There was no report of serious or permanent patient harm or injury.Additional information was received indicating a thermal event had occurred to the device power cord.The user refused to answer any questions as to whether there was exposure to the ac wiring of the cord.The user also is still using the device; therefore, no investigation findings are available.Based on the information available, the manufacturer concludes no further action is necessary at this time.If further information becomes available, or the device and power accessories are returned for investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, and mechanical ventilator devices.The manufacturer received information alleging particle in device coughing up blood, nasal/throat irritation or soreness.There was no report of serious or permanent patient harm or injury.In previous report g3 date was (b)(6) 2022.The correct g3 date should be (b)(6) 2022.In this report section g3 has been updated/ corrected.

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 visualization of particles and a thermal event had occurred to the device power cord related to a bipap device's sound abatement foam.The patient has alleged particle in device, nasal/throat irritation or soreness, coughing up blood.There was no report of serious patient harm or injury.                                                                                                                                                                                                      repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information. the manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section d5 corrected and section h6 updated in this report.

• Brand Name: DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONIC, INC; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 2673970028
• MDR Report Key: 15625149
• MDR Text Key: 305163734
• Report Number: 2518422-2022-87220
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022539
• UDI-Public: 00606959022539
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11
• Device Catalogue Number: DSX700H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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