FDA Adverse Event Malfunction Summary report: N

DREAMSTATION 2 ADV AUTO CPAP 2

MDR report key: 17556118 · Received August 16, 2023

Report

Report Number: 2518422-2023-19838
Event Type: Malfunction
Date Received: August 16, 2023
Date of Event: May 27, 2021
Manufacturer: RESPIRONICS, INC.
Product Code: BZD
PMA / PMN Number: K200480
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN OPENED BY THE MANUFACTURER TO ADDRESS THE WATER INGRESS IDENTIFIED UPON INVESTIGATION.

Description of Event or Problem · 0

THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE ERROR CODE DISPLAYED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. IN EVALUATION IT IS FIND THAT THE DEVICE IS DISPLAYING "THERE MAY BE A PROBLEM WITH YOUR HUMIDIFIER. THERAPY WILL RUN WITHOUT HUMIDIFICATION". DEVICE LOG HAS 1 E100 THEN MANY E101 - ERR_HUMID_NO_HEAT AND ERR_HUMID_MAX_TEMP. THIS GIVES THE INDICATION THE HUMIDIFIER PLATE TCO OPENED DUE TO BEING HEATED TO A TEMP EXCEEDING THE TCO MELTING POINT. SW VERSION V1.0.1.3491. OPENED UP DEVICE AND CLEAR SIGNS OF WATER DAMAGE TO PCA COMPONENTS. E100, 101, 250 NOTED IN MEMORY. THE DEVICE FORWARDED TO PHILIPS PRODUCT INVESTIGATIONS LAB, FAILURE MODE CONFIRMED AND UNIT SUBSEQUENTLY. 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
893651	DREAMSTATION 2 ADV AUTO CPAP 2	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	BZD	RESPIRONICS, INC.	DSX520H11C

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown