MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO, FR; VENTILATOR, (NON-LIFE SUPPORTING )

Model Number FRX500S14

Device Problem Crack (1135)

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

Event Date 09/30/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacture.

Event Description

The manufacturer received information related to a dreamstation cpap.The device was returned to a third party service center.The service technician evaluated the device and found that the device does not turn on.The service technician reports that the power connector is corroded and the device has dust and dirt contamination.There is no allegation of serious injury or patient harm.No medical intervention reported.

• Brand Name: DREAMSTATION AUTO, FR
• Type of Device: VENTILATOR, (NON-LIFE SUPPORTING )
• 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: 18070458
• MDR Text Key: 327374337
• Report Number: 2518422-2023-28901
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: 505
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1