MAUDE Adverse Event Report: DEVILBISS HEALTHCARE IGO2-125 SERIES PORTABLE OXYGEN CONCENTRATOR - DC POWER; GENERATOR, OXYGEN, PORTABLE

Model Number	DV6X-619
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Res recall number has yet to be issued.
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a report of a dc car charger by the provider, who stated that the charger tip burned the end user's hand during use.The end user placed ice on the contact spot.There was no serious injury that required medical attention.Although the end user sustained a burn related to the use of the device, the information provided indicates no medical intervention was required and thus not a reportable serious injury.This device is being recalled.The res recall number has yet to be issued.The root cause is that the supplier of the charger switched the location of the fuse and the spring during assembly.There have been no complaints of serious injury to date associated with this issue.There has been one other subjective complaint of minor thermal injury to fingers/hand reported to date, which resulted in minor transient pain, and no need for medical intervention.These two complaints represent (b)(4) of the at risk population of devices.

• Brand Name: IGO2-125 SERIES PORTABLE OXYGEN CONCENTRATOR - DC POWER
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 21854445
• Report Number: 2515872-2025-00013
• Device Sequence Number: 15433083
• Product Code: CAW
• UDI-Device Identifier: 00885304020585
• UDI-Public: (01)00885304020585
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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: DV6X-619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown