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

Model Number	1020007
Medical Device Problem Code	Powder Leak (4069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding an everflo device.The device was returned to a third party service center.During evaluation of the device, it was discovered the device had defective molecular sieves.The device sieve leaked and the interior of the device was full of white power.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.
Additional Manufacturer Narrative
Reporter phone number listed as: (b)(6).Device not returned to the manufacturer.
Additional Manufacturer Narrative
Correction - not reportable the material in the sieve canisters is compatible with the following biocompatibility standards: iso 10993-1, iso 18562, cm-12.Leakage of sieve canisters is a indictive of past due device preventative maintenance.The sieve dust material exposure is not in the airway path of the canula.The risk document states this is an acceptable risk.This is not reportable.

• Brand Name: EVERFLO
• Common Device Name: 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19244129
• Report Number: 2518422-2024-25069
• Device Sequence Number: 7383904
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: 00606959032569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown