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U.S. Department of Health and Human Services

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

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RESPIRONICS, INC. SIMPLYGO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1069058
Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 12/21/2015
Event Type  Death  
Event Description

The manufacturer received information that a patient expired while using a simplygo oxygen concentrator on an airplane. It was noticed the battery had depleted. It was reported, by the distributor, that when the patient ordered the device that it was only being used for nocturnal use and that one battery would be sufficient. The patient did not have back up oxygen. The simplygo device is not intended to be life-sustaining or life-supporting. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be submitted when the manufacturer has completed the investigation.

 
Manufacturer Narrative

The manufacturer previously reported a patient expired while using a simplygo oxygen concentrator on an airplane. It was observed that the battery had depleted. It was reported, by the distributor, that when the patient ordered the device that it was only being used for nocturnal use and that one battery would be sufficient. The patient did not have a backup supply of oxygen. The device is not returning to the manufacturer for evaluation. The manufacturer received information from the lawyers stating an expert in charge of a public prosecutor's office could not determine a defect on the device and the device was returned to (b)(6). It appears the device operated to design specifications. Loss of therapy for the patient population does not represent a significant risk to the intended user. The simplygo oxygen concentrator is not intended to be life sustaining or life-supporting. Product labeling states, "in an event of an equipment alarm or if you are experiencing any signs of discomfort consult your home care provider. Product labeling also states where the prescribing health care professional has determined that an interruption in the supply of oxygen, for any reason, may have serious consequences to the user, an alternate source of oxygen should be available for immediate use. " the manufacturer concludes that based on the information received from the lawyers, the device operated properly. The device did not cause or contribute to the patient's death since the device is not a life sustaining or life support device.

 
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Brand NameSIMPLYGO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
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 Key5366830
MDR Text Key35960676
Report Number1040777-2016-00002
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK111885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number1069058
Device Catalogue Number1069058
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/05/2014
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: 01/14/2016 Patient Sequence Number: 1
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