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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; BREATHING CIRCUIT CIRCULATOR
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NULL; BREATHING CIRCUIT CIRCULATOR Back to Search Results
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
It was reported that during pre-test, a tear in the breathing bag was found.No patient injury was reported.No additional information is available for this complaint.
 
Manufacturer Narrative
Other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue was confirmed.Although the device was received damaged, it is concluded that failure reported could not be reproduced in the manufacturing process according to the analysis mentioned above.Due to customer have not provided lot number of the component returned, there is not documentation to review the history of the process.
 
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Type of Device
BREATHING CIRCUIT CIRCULATOR
Manufacturer (Section G)
NULL
MDR Report Key12562505
MDR Text Key274274758
Report Number3012307300-2021-09719
Device Sequence Number1
Product Code CAG
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 Other
Type of Report Initial,Followup
Report Date 12/30/2021
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 Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/01/2021
Initial Date FDA Received10/01/2021
Supplement Dates Manufacturer Received12/03/2021
Supplement Dates FDA Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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