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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 35 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 35 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV254T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
Height: 170 cm. Investigation: visual inspection: no significant deformations or damage of the valve was detected during the visual inspection. Permeability test: a permeability test has indicated that the valve has a blockage. Adjustment test: this is a fixed pressure valve. An adjustment test is not applicable. Braking force and brake function test: this is a fixed pressure valve. A braking force and brake function test is not applicable. Computer controlled test: because the valve is not permeable, a computer controlled test is not possible. Results: first, we performed a visual inspection of the shunt assistant. No significant deformations or damage of the valve was detected during the visual inspection. Next, we tested the permeability of the valve. The valve was shown to have a blockage. Finally, we have dismantled the valve. There were no visible deposits observed inside the valve. However, even a small amount of blood or protein that is not visible can lead to temporary blockage and could be responsible le for the suspected malfunction in the past. Based on our investigation, we could detect a blockage of the valve. Therefore, we were unable to check the suspected over drainage. We can exclude a defect a the time of release. The valve met all specification of the final inspection when released from christoph meithke (b)(4).
 
Event Description
It was reported that a valve is over draining. The reporter indicated that a 3 month 5 day post-operative valve was over draining and required explantation. Additional event details were not provided.
 
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Brand NameSHUNTASSISTANT 35
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9634140
MDR Text Key179414952
Report Number3004721439-2020-00028
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K110206
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV254T
Device Catalogue NumberFV254T
Device Lot Number20040029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/27/2020 Patient Sequence Number: 1
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