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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD INC. SMITHS MEDICAL PORTEX THERMOVENT® HEAT AND MOISTURE EXCHANGER FILTERS; FILTER, BACTERIAL, BREATHING-CIRCUIT
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SMITHS MEDICAL, ASD INC. SMITHS MEDICAL PORTEX THERMOVENT® HEAT AND MOISTURE EXCHANGER FILTERS; FILTER, BACTERIAL, BREATHING-CIRCUIT Back to Search Results
Catalog Number 002823P
Device Problem Output Problem (3005)
Patient Problems Cyanosis (1798); Respiratory Distress (2045)
Event Date 06/01/2019
Event Type  Injury  
Event Description
Information was received that a smiths medical gas port was replaced following a high pressure alarm sounding on the respiratory.It was reported patient could not breathe and cyanosis appeared at the time of the alarm.When the product was disconnected, the respiratory condition improved, but when the product was connected again, breathing deteriorated once more.Product had been used every day for a week prior to this incident, during which the patient had complained of respiratory problems several times.No further adverse events reported.
 
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Brand Name
SMITHS MEDICAL PORTEX THERMOVENT® HEAT AND MOISTURE EXCHANGER FILTERS
Type of Device
FILTER, BACTERIAL, BREATHING-CIRCUIT
Manufacturer (Section G)
SMITHS MEDICAL, ASD INC.
boundary road
kent,
UK  
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key8757557
MDR Text Key149924600
Report Number3012307300-2019-02863
Device Sequence Number1
Product Code CAH
UDI-Device Identifier15019315083303
UDI-Public15019315083303
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K033008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number002823P
Device Lot NumberLT1807
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
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