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

Model Number DS560S

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Vertigo (2134); Dizziness (2194); Epistaxis (4458); Unspecified Respiratory Problem (4464); Total Hearing Loss (4473); Dry Mouth (4485)

Event Date 10/09/2023

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 nose infection that leads to an ear infection and loss of hearing in one ear, vertigo, headaches, bloody nose, allergies, phlegm, dry throat/mouth, dizziness, and breathing difficulty/shortness of breath.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• 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: 18532296
• MDR Text Key: 333086243
• Report Number: 2518422-2024-03155
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005884
• UDI-Public: 00606959005884
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560S
• Device Catalogue Number: DS560S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2016
• 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