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U.S. Department of Health and Human Services

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

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RESPIRONICS, INC. SIMPLYGO MINI OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
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.

 
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Brand NameSIMPLYGO MINI OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, 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 Key9081685
MDR Text Key180783466
Report Number1040777-2019-00041
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
PMA/PMN NumberK111858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
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 Received09/18/2019
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 09/18/2019 Patient Sequence Number: 1
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