MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX804T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that a m.Blue plus (#fx804t) showed calibration problems.The complainant device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the malfunction.

Manufacturer Narrative

Manufacturing data: due to the missing product information (e.G.Serial number/delivery note batch), we were unable to trace the production of affected product.We can assure you that all our products are manufactured by qualified staff and individually tested before they are placed on the market.Conclusion information: an investigation was not possible because the product is not available.A final clarification of the cause what has led to non- adjustability; preoperative, is only possible by an examination.Actions: no further actions are required as a result of the complaint.

Event Description

It was reported that a m.Blue plus (#fx804t) showed calibration problems.The complainant device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of the malfunction.

• Brand Name: M.BLUE PLUS VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 19116536
• MDR Text Key: 341249477
• Report Number: 3004721439-2024-00083
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention