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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO INTL OPI 230V EU; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. EVERFLO INTL OPI 230V EU; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 1020006
Device Problems Overheating of Device (1437); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer.
 
Event Description
The manufacturer was contacted about an everflo device with allegations of no oxygen flow and overheating.There are no serious injuries, patient harm, or medical intervention specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
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Brand Name
EVERFLO INTL OPI 230V EU
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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 Key18416230
MDR Text Key331590089
Report Number2518422-2023-38420
Device Sequence Number1
Product Code BZD
UDI-Device Identifier00606959032552
UDI-Public00606959032552
Combination Product (y/n)N
Reporter Country CodePL
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 Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1020006
Device Catalogue Number1020006
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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