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

Model Number 1068987

Device Problems Failure to Power Up (1476); Excessive Heating (4030)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

A simplygo portable oxygen concentrator was returned to the manufacturer for service and an allegation of thermal pca/no power condition.There was allegation of the device burned and melted at the pb board.No void or gaps were found in the enclosure of the device.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the allegation of a thermal pca/no power condition was confirmed.Pca component q61 (battery charging circuit) has shorted to the ground and vented from an over current.A visual inspection of the device found missing enclosure fasteners, evidence of water ingress, dirt/dust/biological dander throughout the unit/cooling path, physical damage to the main pca (components bent 90 degrees to designed orientation), and thermal creep isolated to component and lands only.The exterior battery failed due to cell imbalance and the battery charging circuit fusible link opened.The investigation additionally found there was lack of maintenance, evidence of a dropped condition, liquid ingress, and tampering.

• Brand Name: SIMPLYGO
• 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: 17798547
• MDR Text Key: 324044490
• Report Number: 2518422-2023-24091
• Device Sequence Number: 1
• Product Code: CAW
• 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: Consumer
• 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: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1