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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL ANESTHESIA BREATHING CIRCUIT

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NULL ANESTHESIA BREATHING CIRCUIT Back to Search Results
Model Number CA24K0/4K2/004JP
Device Problem Break (1069)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
It was reported that during pre-test, a part of the product was found damaged. No patient injury reported. No additional information available for this complaint.
 
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Type of DeviceANESTHESIA BREATHING CIRCUIT
Manufacturer (Section G)
NULL
MDR Report Key12577987
MDR Text Key274790575
Report Number3012307300-2021-09762
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCA24K0/4K2/004JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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