MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP, JP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1127899

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging that the adapter generated heat from the dreamstation auto cpap, jp device and the patient received burns above the elbow due to the adapter always being hot.The patient alleges receiving a blister resulting from the burn.There is no indication in the complaint on the status of the blister nor if the patient received medical attention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

• Brand Name: DREAMSTATION AUTO CPAP, JP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18197038
• MDR Text Key: 328922640
• Report Number: 2518422-2023-31399
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1127899
• Device Catalogue Number: 1127899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male