MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. SIMPLYGO MINI OXYGEN CONCENTRATOR; \GENERATOR, OXYGEN, PORTABLE

Model Number	1133943
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a simply-go mini ac adaptor had ignited or sparked.The ac adaptor had evidence of thermal damage exposing wires.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a simplygo mini ac adaptor had allegedly ignited or sparked.The ac adaptor had evidence of thermal damage exposing wires.There was no report of patient harm or injury.The power supply and power cord was returned to the manufacturer's quality product investigation laboratory for further investigation.The manufacturer visually inspected the return parts.The manufacturer found 2 exposed 19.0vdc conductors from overstressed connector.The manufacturer also found several markings consistent with the power cord being pinched or continuously being forced against a hard surface.There was no report of thermal damage to the power supply or power cord.The power supply was applied power and the manufacturer confirmed the power supply provieded 19.0 vdc.When the conductors were manipulated side to side, an intermittent short to ground occurred.Power supply and power cord need to be replaced to address the issue.Product labeling states'"periodically inspect electrical cords, cables, and the power supply for damage or signs of wear.Discontinue use and replace if damaged.".

• Brand Name: SIMPLYGO MINI OXYGEN CONCENTRATOR
• Common Device Name: \GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14763240
• Report Number: 2518422-2022-43983
• Device Sequence Number: 19155950
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: 00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown