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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC OXYGEN/AEROSOL EASIVENT MASKS; MASK, OXYGEN
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SMITHS MEDICAL ASD, INC OXYGEN/AEROSOL EASIVENT MASKS; MASK, OXYGEN Back to Search Results
Catalog Number 20725
Device Problem Defective Device (2588)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The lot number is unknown.
 
Event Description
Information was received indicating that a smiths medical portex aerosol and oxygen easivent mask was no longer working.The device was prescribed for asthma and the patient uses it in conjunction with an inhaler.The patient reported that after two weeks of using the device, the part that goes into the mouth has a white fabric that has sections and one of the sections of the fabric pulled away and came off.There were no adverse events reported.
 
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Brand Name
OXYGEN/AEROSOL EASIVENT MASKS
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
6250 shier rings road,
dublin, oh
Manufacturer Contact
dave halverson
6000 nathan lane north
minneaplois, mn 
3833310
MDR Report Key9975785
MDR Text Key188520253
Report Number3012307300-2020-03164
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number20725
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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