MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for PROSA VALVE FV701T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188553529]
Height: 180cm investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection. The prosa valve housing was subsequently measured and confirmed the presence of a deformation. The housing deformation measured at -0. 0895 mm, outside the tolerance of 0? 0. 02 mm. Permeability test: a permeability test has shown that the prosa valve is permeable. Adjustment test: the prosa valve was tested and could be adjusted in all pressure ranges without any form of force being required. The brake is damaged is adjustable without to all specified pressures. Braking force and brake function test: the brake functionality test has shown that the brake function did not operate as expected. The results indicate that the rotor no longer performs as required. Results: first, we performed a visual inspection of the prosa valve. A deformation of the outer housing of the prosa valve was observed through the visual inspection. This deformation was confirmed through a measurement of the plan parallelity. Next we tested the permeability, adjustability, the brake functionality and brake force. The valve is permeable, but the brake is damaged and the braking force is no longer available. Finally, we have dismantled the valve. There were no visible deposits observed inside the valve. Based on our investigation results, we can confirm the suspicion that "the valve adjusts by itself" at the time of our investigation. We assume that the observed deformation is the cause of the functional impairment of the adjustability. The cause of the deformation of the prosa valve and the resultant defect of the rotor could not be determined through our investigation. Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve. We can exclude a defect at the time of release. The valve met all specifications of the final inspection when released from christoph miethke (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188553530]
It was reported that there is an issue with valve. The reporter indicated that a post-operative valve does not hold pressure. The device was explanted. Additional event details is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00068 |
| MDR Report Key | 9868384 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-11-01 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOERG KNEBEL |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14469 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSA VALVE |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-09 |
| Model Number | FV701T |
| Catalog Number | FV701T |
| Lot Number | 20044492 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Address | 2 ULANENWEG POTSDAM D, 14469 GM 14469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |