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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. SIMPLYGO MINI; PORTABLE OXYGEN CONCENTRATOR
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RESPIRONICS, INC. SIMPLYGO MINI; PORTABLE OXYGEN CONCENTRATOR Back to Search Results
Model Number 1113605
Device Problems Inaccurate Flow Rate (1249); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2023
Event Type  malfunction  
Event Description
The manufacturer received information regarding a simplygo mini.The device was returned to the manufacturer's warehouse.Per the work order, the device was noisy.The compressor was replaced.During inspection of the device, the device was found to have o2 side assembly component failure, the air side manifold was cracked, low o2, and no power flowing to the power connector.All failing components were replaced.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.
 
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Brand Name
SIMPLYGO MINI
Type of Device
PORTABLE OXYGEN CONCENTRATOR
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 Key18379949
MDR Text Key331205336
Report Number2518422-2023-37325
Device Sequence Number1
Product Code CAW
UDI-Device Identifier00606959032439
UDI-Public00606959032439
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K111885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
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 Received12/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1113605
Device Catalogue Number1113605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2023
Date Manufacturer Received11/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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