MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number FRX1130S14

Device Problems Degraded (1153); Contamination /Decontamination Problem (2895)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information regarding a dreamstation avaps.The device was returned to a third-party service center.During visual inspection of the device, corrosion was found on the power connector.In addition, the inspection found other contamination of dust or dirt was found inside the device.This report is being submitted for the corrosion found on the power connector during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• Brand Name: DREAMSTATION AVAPS30
• Type of Device: VENTILATOR, CONTINUOUS, 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: 18265171
• MDR Text Key: 329671034
• Report Number: 2518422-2023-33401
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• 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: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FRX1130S14
• Device Catalogue Number: FRX1130S14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1