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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/10/2019

Event Type  malfunction  

Event Description

The manufacturer received information alleging a patient was using a simplygo mini oxygen concentrator with a tracheostomy.The device was alarming for no breaths detected.The patient went to the emergency room for low blood oxygen levels but was not admitted.The patient was given a concentrator.The device is not returning to the manufacturer's service center for evaluation.It appears the pulse dose simplygo mini oxygen concentrator was the incorrect device to be used on a patient with a tracheostomy.Product labeling states,"the device detects when the user begins to take a breath and then delivers a pulsed volume of oxygen during the inhalation period.The volume of the oxygen pulse is dependent on the setting value.If no breath is detected for a period of time, the system automatically delivers the pulsed volume of oxygen determined by the setting number at a fixed rate of 12 breaths per minute.If no breath is detected for 2 minutes, the device signals an alarm and shuts down after 15 minutes if the device is running on battery power." "the device is to be used with a standard single lumen nasal cannula, up to 10 ft.Proper placement and positioning of the nasal cannula in the nose is critical to the consistent operation of the simplygo mini." the manufacturer concludes that this was the incorrect device to be used with this patient.

• Brand Name: SIMPLYGO MINI OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 9081685
• MDR Text Key: 180783466
• Report Number: 1040777-2019-00041
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K111858
• 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
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR