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

Model Number DS550S

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Choking (2464)

Event Date 09/24/2021

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 has alleged to choking.There was no report of serious patient harm or injury.There was no medical intervention 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 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 previously received information alleging device chokes the patient at the time of wear it, related to a cpap device's sound abatement foam.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The external aspect of the device was inspected visually and and the manufacturer observed no signs of contamination on the outside of the device.The internal aspect of the device was inspected and contamination on flip lid seal of the humidifier was observed.The manufacturer also observed signs of contamination on the bottom enclosure of the base unit.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation, but a small amount dust contamination were observed and are consistent with being from an external source.Section d8, d9, h2, h3 and h6 were updated in this report.Section d1, d4, g4 and h4 has been corrected in this report.

• Brand Name: REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15743760
• MDR Text Key: 305916352
• Report Number: 2518422-2022-91125
• 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,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS550S
• Device Catalogue Number: DS550S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2011
• 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