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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREAT GROUP MEDICAL CO. LTD RESPIRATORY HUMIDIFIER TEMPERATURE PROBE LEAD 1.5M; FL9000-03U TEMPERATURE PROBE LEAD
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GREAT GROUP MEDICAL CO. LTD RESPIRATORY HUMIDIFIER TEMPERATURE PROBE LEAD 1.5M; FL9000-03U TEMPERATURE PROBE LEAD Back to Search Results
Catalog Number FL9000-03U
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Manufacturer Narrative
The device is being returned for evaluation.Once returned tests will be carried out to investigate root cause.This will include checking compatability of cleaning materials used on device.
 
Event Description
Temperature probes were discovered cracked while seated inside the circuit.Significant rainout occurred.Blue portion of temperature probe broke off and was found floating in the inspiratory side of the circuit.
 
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Brand Name
RESPIRATORY HUMIDIFIER TEMPERATURE PROBE LEAD 1.5M
Type of Device
FL9000-03U TEMPERATURE PROBE LEAD
Manufacturer (Section D)
GREAT GROUP MEDICAL CO. LTD
no. 168 xingong 2nd rd.
tianzhong township
changua county 520, taiwan
TW 
MDR Report Key11684279
MDR Text Key257183528
Report Number3006061749-2021-00006
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K161314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Catalogue NumberFL9000-03U
Device Lot Number70401416-0259
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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