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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ESIVENT; NEBULIZER (DIRECT PATIENT INTERFACE) PRODUCT CODE: CAF
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SMITHS MEDICAL ASD, INC. ESIVENT; NEBULIZER (DIRECT PATIENT INTERFACE) PRODUCT CODE: CAF Back to Search Results
Catalog Number 20725
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received that during the use of a smiths medical easivent nebulizer, the round mouthpiece broke off entirely from the base of the valved holding chamber that patient placed to her mouth to inhale the medication.No adverse patient effects were reported.
 
Manufacturer Narrative
Additional information: h6, h10.Device evaluation: one smiths medical level 1 h-1200 fast flow fluid system was returned for analysis in a good condition.During analysis, the reported problem was not able to be duplicated.Ran device for 3 hours and no air-in-line alarm came on.Based on the evidence, the complaint was not confirmed, and no fault was found.
 
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Brand Name
ESIVENT
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE) PRODUCT CODE: CAF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9685074
MDR Text Key182419218
Report Number3012307300-2020-00954
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/16/2024
Device Catalogue Number20725
Device Lot Number3736113
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/09/2020
Initial Date FDA Received02/09/2020
Supplement Dates Manufacturer Received03/17/2020
Supplement Dates FDA Received04/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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