LIV VALVE ROTAREX / CEODEUX REF: LIV LINDE DISS 0,750-16UNF MAXIFLOW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2015-04-01 for LIV VALVE ROTAREX / CEODEUX REF: LIV LINDE DISS 0,750-16UNF MAXIFLOW manufactured by .

Event Text Entries

[5732360] This spontaneous med device incident report from a customer in (b)(6), the (b)(6), involves a stem of cylinder linde integrated valve (liv) manufactured by (b)(4). On (b)(6) the (b)(6) reported an incident concerning a liv, which presented a valve fracture at the stem. The incident occurred when the cylinder was not in use and stowed with nine more cylinders. The incident did not cause harm to people but it caused minor damages to the infrastructure of the storage area at the customer's site. The cylinder and valve were immediately collected for further investigation and material analysis. A recall has been initiated by the plant. This case is linked to co-lhc-2015040 due to similar incidents from the same batch. Due to the similarity of failure mechanism and the same location these incidents are subject to a common investigation and will be managed as a single mir, 15-25 ras. Cylinder brand: luxfer, 5 liters (portable type). Valve brand and reference: liv valve (b)(4) reference liv linde diss 0,750-16unf maxiflow, both equipment suitable for filling at 200 bar. Risks: the detachment of the valve might hit other cylinders or valves causing an ignition after spark generation. The sudden release of pressure and consequent expel of the valve can impact operators or third parties, damage equipment or infrastructure. Additional info is expected.
Patient Sequence No: 1, Text Type: D, B5


[13181545] Report from (b)(6); cylinder neck broken, unclear whether there possibly could be a device defect or if it is associated to external forces. Investigation ongoing. Device incident, no pt/human harm.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003900188-2015-00003
MDR Report Key4663980
Report Source00,01,05
Date Received2015-04-01
Date of Report2015-04-01
Date of Event2015-03-02
Date Mfgr Received2015-03-02
Date Added to Maude2015-05-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer StreetAGAVAGEN 54
Manufacturer CityLIDINGO 181 81
Manufacturer CountrySW
Manufacturer Postal181 81
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIV VALVE ROTAREX / CEODEUX REF: LIV LINDE DISS 0,750-16UNF MAXIFLOW
Generic NameNONE
Product CodeECX
Date Received2015-04-01
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-01

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