MAUDE Adverse Event Report: RESPIRONICS,INC DREAMSTATION BIPAP AUTOSV H/HT/C, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Unspecified Respiratory Problem (4464)

Event Date 07/08/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop pulmonary fibrosis.There is no report of the medical intervention that the patient has received at this time.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 allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: b3 date of event: previously reported as on (b)(6) 2021 ; updated to on (b)(6) 2021.

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 a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop pulmonary fibrosis.Additional information was received, and the patient reported that they had a heart attack and difficulty breathing/short of breath and after one year of use, has pulmonary fibrosis and is progressing, with areas of sub-pleural reticulation at the lung base.The patient also reported that they noticed a long hair similar to a cat hair, about 2 mm long, on his pillow but were not sure if this was anything or not.This event is assessed as not related to the device in this case.The device did not cause or contribute to the alleged serious 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 an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 health effect - clinical code has been added, and type of investigation, investigation findings, and investigation conclusions have been updated.

• Brand Name: DREAMSTATION BIPAP AUTOSV H/HT/C, DS
• 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: 12324403
• MDR Text Key: 266639784
• Report Number: 2518422-2021-03202
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 08/22/2023
• Supplement Dates FDA Received: 09/03/2021; 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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
• Treatment: ATENOLOL.; ATORVASTATIN.; CPAP.; DSXHCP (DREAMSTATION HUMIDIFIER).
• Patient Outcome(s): Life Threatening; Disability; Other