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

Model Number DS560S

Device Problems Degraded (1153); Device Emits Odor (1425); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Device not returned to the 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Update: the patient additionally reported the device shut off on its own once while still in use.The patient also alleges the device had a strange odor shortly before the device was replaced.The patient admitted the device was likely not cleaned as often as it should have been, and stated a soclean device and baby shampoo was used to clean the unit.The patient stated "i couldn't handle the lingering ozone odor when i would use the cpap at that night after cleaning." the patient stopped using the device due to being afraid of using it with the strange smell.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Section h: (device) problem code grid : added "device emits odor" and "unexpected shutdown".

• 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: 18682826
• MDR Text Key: 335194524
• Report Number: 2518422-2024-06761
• Device Sequence Number: 1
• Product Code: BZD
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2024
• Is this an Adverse Event Report?: No
• 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: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2014
• 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