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); Dizziness (2194); Sore Throat (2396); Convulsion/Seizure (4406); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The previously reported follow up report, mdr 2518422-2022-07361-1 was incorrectly submitted with the information of mdr 2518422-2021-07361-1.

Manufacturer Narrative

The manufacturer previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no patient harm or injury.The patient also alleged of having shortness of breath, headaches, sore throat, dizziness, sinuses issues, nose, ears and seizures.

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 receive alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles in the air path.There was no report of 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 an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, followup 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 15206 ; 2673970028
• MDR Report Key: 13619043
• MDR Text Key: 296587814
• Report Number: 2518422-2022-07361
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• 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