FDA Adverse Event Malfunction Summary report: N

REP DREAMSTATION AUTO CPAP

MDR report key: 24206449 · Received January 28, 2026

Report

Report Number
2518422-2026-100236
Event Type
Malfunction
Date Received
January 28, 2026
Date of Event
January 20, 2026
Report Date
January 29, 2026
Manufacturer
RESPIRONICS, INC.
Product Code
BZD
UDI-DI
00606959428539
PMA / PMN Number
K131982
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

A REP DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO MANUFACTURER'S SERVICE CENTER FOR INVESTIGATION WITH COMPLAINT OF A PECULIAR SMELL SUCH AS SHORT-CIRCUIT OCCURRED FROM THE RESPIRATORY CIRCUIT AND AIR SENDING STOPPED 5 MINUTES AFTER STARTING TO USE CPAP DEVICE, THEN THE ERROR "REQUIRED CHECK/INSPECT" WAS DISPLAYED. DURING THE INVESTIGATION, THE OCCURRENCE OF "SERVICE REQUIRED" DISPLAYED WAS NOT CONFIRMED. SINCE A PECULIAR SMELL SUCH AS SHORT-CIRCUIT WAS OBSERVED, THE FOLLOWING PARTS WERE REPLACED: REAR PANEL AND RP KIT. A BURNOUT ON THE BOARD WAS OBSERVED AFTER AN INSPECTION FOR THE INSIDE OF THE DEVICE, BUT THE CAUSE WAS NOT IDENTIFIED, THE THERAPY PCA WAS REPLACED DUE TO THE BURNOUT, THE UPPER ENCLOSURE WAS REPLACED DUE TO BURNT STAINS OBSERVED, THE ACCESSORY MODULE FLIP DOOR WAS ATTACHED SINCE IT WAS MISSING. THE DEVICE WAS FURTHER SENT TO PIL FOR ADDITIONAL EVALUATION. DURING THE INVESTIGATION, THE MANUFACTURER OBSERVED A THERMAL EVENT AT Q8 PHILIPS PN 1091127 XSTR MOSFET PCHAN ROHS 30V SSOT-6 SMT (SEE ER2243104) TO THE PCA. PIL CONNECTED THE PCA (PRINTED CIRCUIT ASSEMBLY) TO A KNOWN GOOD DREAMSTATION 1 DEVICE (ETF 3100684-001) AND POWERED ON DEVICE. PIL INITIATED THERAPY AND VERIFIED AIRFLOW. PIL USED THE SERVICE CENTER TOOLS EFS 4104084 V4.9 PROGRAM TO RETRIEVE THE ERROR LOG AND OBSERVED QUANTITY OF NO ERRORS WERE LOGGED. SUSPECT ERRORS WERE CLEARED. PIL SUSPECT SERVICE REQUIRED MESSAGE DUE TO A THERMAL EVENT AT Q8 (ER2243104). THE DEVICE WAS SCRAPPED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
267416 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RJPX500S16F 00606959428539

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown