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

Model Number	1068987
Medical Device Problem Codes	Failure to Power Up (1476); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A simplygo portable oxygen concentrator was returned to the manufacturer for service and an allegation of thermal pca/no power condition.There was allegation of the device burned and melted at the pb board.No void or gaps were found in the enclosure of the device.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the allegation of a thermal pca/no power condition was confirmed.Pca component q61 (battery charging circuit) has shorted to the ground and vented from an over current.A visual inspection of the device found missing enclosure fasteners, evidence of water ingress, dirt/dust/biological dander throughout the unit/cooling path, physical damage to the main pca (components bent 90 degrees to designed orientation), and thermal creep isolated to component and lands only.The exterior battery failed due to cell imbalance and the battery charging circuit fusible link opened.The investigation additionally found there was lack of maintenance, evidence of a dropped condition, liquid ingress, and tampering.

• Brand Name: SIMPLYGO
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17798547
• Report Number: 2518422-2023-24091
• Device Sequence Number: 20274097
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2018
• 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