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

Model Number DS550HS

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Headache (1880); Dizziness (2194); Sore Throat (2396); Unspecified Respiratory Problem (4464); Eye Pain (4467)

Event Date 10/04/2021

Event Type  malfunction  

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 alleged visualization of particles, eye pain, fatigued,nasal/throat irritation or soreness, light headed, dizziness and headaches.There was no report of serious or permanent patient harm or injury.Medical intervention was not specified.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 BZD
• 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: 16032248
• MDR Text Key: 306067263
• Report Number: 2518422-2022-102791
• 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
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• 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: 10/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1