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

Model Number	1113602
Medical Device Problem Codes	Vibration (1674); Insufficient Flow or Under Infusion (2182); Tear, Rip or Hole in Device Packaging (2385); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information regarding a simplygo mini.The device was returned to a third party service center.A repair work order and invoice was received from the third party service center that mentioned the device's sieve beds contained low o2, the motor was noisy and vibrating, the manifold assembly was cracked, and the power connector was damaged.The unit would not start and it was also mentioned that the shipping box was damaged.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• 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: 18381712
• Report Number: 2518422-2023-37376
• Device Sequence Number: 18042611
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: 00606959032408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: Other
• Device Model Number: 1113602
• Device Catalogue Number: 1113602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown