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U.S. Department of Health and Human Services

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

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RESPIRONICS INC SIMPLYGO MINI GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1113602
Device Problem Break (1069)
Patient Problems Sprain (2083); Injury (2348)
Event Date 12/08/2016
Event Type  Injury  
Manufacturer Narrative

The device is not returning to the manufacturer for evaluation.

 
Event Description

The manufacturer received information alleging a simplygo mini oxygen concentrator's strap broke reaggravating the patient's previously injured shoulder. The patient required physical therapy. Product labeling states, "only use the supplied handle and shoulder strap to carry your device. With every use, verify that the case, shoulder strap and handle are in good condition. ".

 
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Brand NameSIMPLYGO MINI
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS INC
175 chastain meadows court
kennesaw GA 30144
Manufacturer (Section G)
RESPIRONICS INC
175 chastain meadows court
kennesaw GA 30144
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key6224757
MDR Text Key63949290
Report Number1040777-2017-00002
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1113602
Device Catalogue Number1113602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/16/2016
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: 01/05/2017 Patient Sequence Number: 1
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