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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; INTUBATON
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SMITHS MEDICAL ASD, INC. PORTEX; INTUBATON Back to Search Results
Model Number 100/322/080
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2020
Event Type  malfunction  
Event Description
Information received a smiths medical intubation|portex airway guedel oropharyngeal when patient was coughing, the green tip of the guedel airway disconnected.They had to change the device.
 
Manufacturer Narrative
Other, other text: correction- no patient death reported.
 
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Brand Name
PORTEX
Type of Device
INTUBATON
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10396942
MDR Text Key203851875
Report Number3012307300-2020-08103
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15019315071416
UDI-Public15019315071416
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type unknown
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number100/322/080
Device Catalogue Number100/322/080
Device Lot Number1910022172
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/13/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received08/13/2020
Supplement Dates FDA Received08/18/2020
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
Patient Outcome(s) Required Intervention;
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