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

Model Number U1113602

Device Problems Sparking (2595); Charging Problem (2892)

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

Event Date 04/30/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a simplygo mini device has a low battery alarm and was smoking when plugged in to wall unit.The user alleged the sparks where the charging port was and charger is shorting.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: RECERT 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: 18959210
• MDR Text Key: 338361317
• Report Number: 2518422-2024-14861
• 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: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U1113602
• Device Catalogue Number: U1113602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male