MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DS550HS

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Pulmonary Dysfunction (2019)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 asthma( new or worsening) and lung disease.Medical intervention was not specified.No patient information was provided.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.

• Brand Name: REMSTAR AUTO A-FLEX
• 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 lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18666755
• MDR Text Key: 334839410
• Report Number: 2518422-2024-06179
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS550HS
• Device Catalogue Number: DS550HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening