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

Model Number DS560HS

Device Problems Degraded (1153); Overheating of Device (1437); Decrease in Pressure (1490); Noise, Audible (3273)

Patient Problems Headache (1880); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 10/23/2023

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 has alleged nasal/throat irritation or soreness, cough, headaches, device/power cord or supply too hot to touch, device was noisy, particles in the device, not enough pressure and uses water fast.There was no report of serious or permanent harm or injury. the device has not yet been returned to the manufacturer for investigation. the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned.

• Brand Name: REMSTAR AUTOA-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18092850
• MDR Text Key: 327637033
• Report Number: 2518422-2023-29341
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005891
• UDI-Public: 00606959005891
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560HS
• Device Catalogue Number: DS560HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2015
• 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