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

Model Number	1020010
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of reported sparking coming from out of the back of a power cord for an everflo opi concentrator.The coating has melted on the back of the power plug before the unit.There was no patient harm or injury reported.No medical intervention was reported.The device was returned to the distributor where the insulator of the power cord was found to be peeled off and had an exposed conductor wire.Sparks were unable to be replicated as repair of the device was conducted first before plugging the unit into ac power for safety reasons.The corrective actions taken were to replace the power cord, compressor, the sieve cannister and change the internal filter before turning on the device upon receipt.The concentrator was tested and confirmed to be working correctly.If any additional information is received, a follow up report will be filed.

• Brand Name: EVERFLO OPI CONCENTRATOR
• 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: 19111165
• Report Number: 2518422-2024-19720
• Device Sequence Number: 8230157
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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