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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO 120V OPI DOMESTIC; GENERATOR, OXYGEN, PORTABLE
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RESPIRONICS, INC. EVERFLO 120V OPI DOMESTIC; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020001
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Event Description
The manufacturer became aware of an allegation of everflo that the unit's flow ball not moving and that it was an out of the box failure.During the evaluation of the device, the service center visually inspected the device and found evidence of the flow ball not moving.The device has been scrapped.
 
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Brand Name
EVERFLO 120V OPI DOMESTIC
Type of Device
GENERATOR, OXYGEN, PORTABLE
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 Key18266651
MDR Text Key329727647
Report Number2518422-2023-33420
Device Sequence Number1
Product Code CAW
UDI-Device Identifier00606959022041
UDI-Public00606959022041
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
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 Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1020001
Device Catalogue Number1020001
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/29/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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