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

Model Number	1113605
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer was previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging black particles spitting out of o2 spout.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The report is changed from uno to non-uno report.The updated b5 will be: the manufacturer became aware that a user of the simplygo mini had stated black particles spitting out of o2 spout.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.  no additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In box h: remedial action init (rfb), remedial action initiated, recall (z) number (rfb) & recall (z) number are updated in this follow-up.
Additional Manufacturer Narrative
The manufacturer previously became aware that a user of the simplygo mini had stated black particles spitting out of o2 spout.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.No additional information can be requested at this time.In box h: problem code grid has been updated in this follow-up.
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging black particles spitting out of o2 spout.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: SIMPLYGO MINII
• 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: 20056364
• Report Number: 2518422-2024-53367
• Device Sequence Number: 18349584
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: (01)00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 04/15/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/26/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown