MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number RJPX500S16

Device Problem Contamination (1120)

Patient Problems Nausea (1970); Rash (2033)

Event Date 07/29/2021

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 the patient is experiencing nausea and rash/inflammation inside the nose from the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.External investigation found small amounts of yellowish contamination on the front panel, on the air filter, and the rental sticker showed yellowing as well.The product investigation lab also found moderate dust/dirt contamination on the front panel behind the rotary knob.Using a known good power supply and power cord, product investigation lab applied power and verified the unit provided airflow.Internal investigation found yellow discoloration, most likely tobacco contamination, on the bottom enclosure, rear panel, and blower outlet seal.A small piece of hard black plastic was found in the joint between the bottom enclosure and the front panel.The blower box also had a slight yellow tint.During the evaluation of the device, the manufacturer visually inspected the device and found no evidence of foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 0 errors logged.The manufacturer was unable to confirm the customer's complaint.The manufacturer confirmed there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16158988
• MDR Text Key: 307594975
• Report Number: 2518422-2023-01693
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RJPX500S16
• Device Catalogue Number: RJPX500S16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male