FDA Adverse Event Malfunction Summary report: N

REP DREAMSTATION AUTO

MDR report key: 21440850 · Received February 22, 2025

Report

Report Number: 2518422-2025-020488
Event Type: Malfunction
Date Received: February 22, 2025
Date of Event: April 18, 2022
Report Date: August 28, 2025
Manufacturer: RESPIRONICS, INC.
Product Code: BZD
UDI-DI: 00606959025646
PMA / PMN Number: K131982
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING EVALUATION SECONDARY FINDINGS WERE NOT OBSERVED. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND DEVICE WAS CORRECTED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. EVALUATION METHOD CODE, EVALUATION RESULTS CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED.

Description of Event or Problem · 0

THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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
1109130	REP DREAMSTATION AUTO	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	BZD	RESPIRONICS, INC.	UDSX500S11F		00606959025646

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown