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

Model Number	1113601
Medical Device Problem Codes	Overheating of Device (1437); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
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 the patient's device is not turning on or off and the device is getting hot when it is plugged in to charge.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacture previously reported an event alleging the patient's device is not turning on or off and the device is getting hot when it is plugged in to charge.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned for evaluation.During the evaluation of the device, the device was visually inspected and found the device appeared to have been dropped and or tampered with.The oxygen sensor pca was found separated from the main pca and header/connector.The blue tubing connected to component pt3 is pinched in between the rear enclosure and the sensor and was found occluded/flat.During the evaluation of the device, the performance evaluation showed that after the device was reconfigured to original designs the unit functioned and performed as designed.The customer allegation of no power was confirmed however, no evidence of thermal event exists.The fault/failure appears to originate external to the unit design.The details of the physical damage/tampering of when/where event occurred are not known.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.

• Brand Name: SIMPLYGO MINI
• 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: 18094323
• Report Number: 2518422-2023-29465
• Device Sequence Number: 6670373
• Product Code: CAW
• UDI-Device Identifier: 00606959032385
• UDI-Public: (01)00606959032385
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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 Age: 72 YR
• Patient Sex: Male