FDA Adverse Event Death Summary report: N

REP DREAMSTATION AUTO CPAP

MDR report key: 19885696 · Received August 1, 2024

Report

Report Number: 2518422-2024-48510
Event Type: Death
Date Received: August 1, 2024
Date of Event: May 24, 2023
Report Date: November 27, 2025
Manufacturer: RESPIRONICS, INC.
Product Code: BZD
PMA / PMN Number: K131982
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE MANUFACTURER PREVIOUSLY REPORTED WAS BEING 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 STATING THAT THE PATIENT HAS PASSED AWAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULT STATED THAT VISIBLE FOAM PARTICLES WERE NOT OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED.

Description of Event or Problem · 0

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 STATING THAT THE PATIENT HAS PASSED AWAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2220831	REP DREAMSTATION AUTO CPAP	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	BZD	RESPIRONICS, INC.	UDSX500S11F

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Death