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

Model Number DSX700H11

Device Problem Degraded (1153)

Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging visualization of particles related to a bipap device's sound abatement foam.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 previously reported an issue related to a cpap, bipap, and mechanical ventilator devices sound abatement foam become degraded and alleged visualization of particles.There was no report of serious patient harm or injury.The manufacturer received additional information that the patient having heart attack.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should 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 an issue related to a bipap device's sound abatement foam.The patient has alleged visualization of particles and heart attack.There was no medical intervention required by the patient.The reported event of heart attack and its reported severity was reviewed by the manufacturer's clinical expert.This event is assessed as not related to the device in this case.Based on the information available, the manufacturer concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect-impact code, type of investigation, investigation findings and investigation conclusions have been updated.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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 ln; murrysville 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 2673970028
• MDR Report Key: 14683960
• MDR Text Key: 293913426
• Report Number: 2518422-2022-42324
• 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
• Report Date: 04/13/2023

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 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
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 10/20/2022
• Supplement Dates FDA Received: 10/20/2022; 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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): Other