MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number CAX521H12C

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : third- party service center.

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap had a water leak.There was no report of smoke, flames, voids, or exposed ac wires.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned to a third-party service center for investigation.During the evaluation of the device, the third-party service center was able to confirm the customer's complaint of the water leak due to thermal damage to the pca from water ingress.The device was repaired.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DS2ADV AUTO CPAP
• 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: 18545452
• MDR Text Key: 333271749
• Report Number: 2518422-2024-03555
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

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: Other
• Device Model Number: CAX521H12C
• Device Catalogue Number: CAX521H12C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1