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

Model Number FR555S

Device Problem Degraded (1153)

Patient Problems Headache (1880); Nausea (1970); Dizziness (2194); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/10/2022

Event Type  malfunction  

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 an issue related to a cpap device's sound abatement foam.The patient has alleged headaches at night and when getting up, irritated throat, cough, irritation of the nose, nausea, dizziness, irritation upper airways, chronic sinusitis, disorders of the ent sphere.Current drug treatment: aerius on demand, avamys following rhinitis and levothyroxine for the thyroid.There was no report of serious patient harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 18952196
• MDR Text Key: 338343286
• Report Number: 2518422-2024-14747
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FR555S
• Device Catalogue Number: FR555S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2012
• 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 Sex: Female