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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA DISP BREATHING CIRCUITS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA DISP BREATHING CIRCUITS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Lot Number 4150589
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
No product was returned. We are unable to confirm the reported complaint. If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Event Description
It was reported that separation from the circuit to the blue filter as well as from the elbow to the y part of the circuit. Occurrences were noted when patients are asleep and supine in the prone position. No patient injury was reported.
 
Manufacturer Narrative
No product was returned. We are unable to confirm the reported complaint. If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Event Description
It was reported that separation from the circuit to the blue filter as well as from the elbow to the y part of the circuit. Occurrences were noted when patients are asleep and supine in the prone position. No patient injury was reported.
 
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Brand NamePORTEX ANESTHESIA DISP BREATHING CIRCUITS
Type of DeviceVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13480550
MDR Text Key286020691
Report Number3012307300-2022-02881
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4150589
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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