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

Model Number R1133943

Device Problems Device Alarm System (1012); Overheating of Device (1437); Gas/Air Leak (2946)

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

Event Date 01/14/2024

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to a simplygo mini device with complaints of the device overheating and a burning smell.There is no allegation of patient harm or serious injury.There was no medical intervention specified.The device was visually inspected/evaluated by the manufacturer.The manufacturer could not confirm the complaint; however, during inspection there were alarms that occurred when running under high load operation and the device did not produce.The manufacturer concluded this could be due to the device operating environment or ventilation obstruction.An internal inspection was also completed and there were no signs of burnt parts.The sieve canister was replaced along with the compressor inlet filter.Due to an internal leak, the sheave 02 side assembly was also replaced.After inspection and running test, the device has been confirmed to be working properly.

• Brand Name: SIMPLYGO MINI
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18544964
• MDR Text Key: 333266886
• Report Number: 2518422-2024-03542
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R1133943
• Device Catalogue Number: R1133943
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1