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

Model Number	1068987
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging a simply go device's battery is burned.The device had technical examinations conducted during bench repair.The engineer reports burn marks have been identified on the pin parts of the device's battery.No burn marks have been found on the parts of the battery line leading to the mainboard.The device was tested with a battery used for testing purposes in the bench, and no external problems have been observed in the battery line.It has been determined by me that the burn problem originates solely from the battery.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device will be returned to the manufacturer for further review.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received information alleging a simply go device's battery is burned.The device had technical examinations conducted during bench repair.The engineer reports burn marks have been identified on the pin parts of the device's battery.No burn marks have been found on the parts of the battery line leading to the mainboard.The device was tested with a battery used for testing purposes in the bench, and no external problems have been observed in the battery line.It has been determined by me that the burn problem originates solely from the battery.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.After the second attempt to have the device and components evaluated, the customer responded that the device will be available for evaluation, but it has not yet been returned to the manufacturer for evaluation.The manufacturer is submitting an updated report at this time.After device return and completion of evaluation, a follow-up report will be filed.Box h: evaluation method code, evaluation results code, component code grid and conclusion code grid has been updated.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a simply go device's battery was burnt.The device had technical examinations conducted during bench repair.The engineer reports burn marks have been identified on the pin parts of the device's battery.No burn marks have been found on the parts of the battery line leading to the mainboard.The device was tested with a battery used for testing purposes in the bench, and no external problems have been observed in the battery line.It has been determined that the burn problem originates solely from the battery.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Despite good faith effort attempts, the device has not yet been returned to the manufacturer for evaluation.At this time, philips is not able to fully investigate this complaint.If any additional information is received, a supplemental report will be filed.Udi related data quality updates only the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.In this report, box d and h10 has been updated/corrected.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18955238
• Report Number: 2518422-2024-14717
• Device Sequence Number: 17288097
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: (01)00606959005723
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2026

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: Other
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/08/2024; 09/03/2025
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/20/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• 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