MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO; GENERATOR, OXYGEN, PORTABLE

Model Number 1020007

Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A ventilator was returned to a third-party service center for service.The patient alleged the device was noisy.There was no harm or injury reported.During the evaluation of the device at third-party service center, the complaint was confirmed.The compressor was noisy.The service technician found that the integrated canisters were clogged, the manifold was contaminated, the power cord was damaged, the pca pressure sensor was defective, and the inlet filter and overlay kit was damaged.

• Brand Name: EVERFLO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• 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: 18272098
• MDR Text Key: 329779094
• Report Number: 2518422-2023-33714
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1