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

Model Number 1113602

Device Problems Vibration (1674); Insufficient Flow or Under Infusion (2182); Tear, Rip or Hole in Device Packaging (2385); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event 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
• Type of Device: 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
• MDR Text Key: 331184255
• Report Number: 2518422-2023-37376
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: 00606959032408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1113602
• Device Catalogue Number: 1113602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1