LIV M70610209

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-24 for LIV M70610209 manufactured by Ceodeux S.a..

Event Text Entries

[70802830] This spontaneous medical device case, concerning a valve ignition with a medical oxygen cylinder fitted with a linde integrated valve (liv) system with a valve manufactured by rotarex / ceodeux, was reported by a healthcare professional in (b)(6) on 22-feb-2017. This report is linked to the non-serious adverse event cases (b)(4). On (b)(6) 2017 the assistant staff at the medicine ward was using a linde medical oxygen (conoxia) cylinder to serve a patient. While opening the valve and adjusting the flow selector from 0 to 2 l/min, a high pressure and a loud sound was detected. A nurse and the hospital staff attempted to set the flow selector back to 0 l/min. However, they could not stop the gas flow by that action. At 9:24 am suddenly a valve ignition occurred. The other assistant staff used the fire extinguisher tank to stop the fire which lasted for 5-10 seconds. The emergency alarm at the hospital was level 3. The hospital emergency response alarm at the hospital was level 3. The hospital emergency response protocol was followed according to the emergency plan instruction. The oxygen valve supply to this ward (zone valve) had to be isolated. There were two patients directly involved in this incident. One was using the linde incident conoxia tank and another stayed close to the incident scene. Both patients were safe and did not get injured from the fire. Four patients were using oxygen service from the pipeline which were impacted from isolation of zone valve to switch using ambu-bag. All were safe. Unfortunately, there were two persons from the hospital staff on the scene who got injured from this incident: one hospital staff experienced 2nd degree burn on the right hand; one nurse student experienced 1st degree burn on the left forefinger. There was no damage from the fire at the hospital's assets. Additional information is expected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003900188-2016-00001
MDR Report Key6432275
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-03-24
Date of Report2017-03-17
Date of Event2017-02-22
Date Mfgr Received2017-02-22
Date Added to Maude2017-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street15TH FLOOR, BANGNA TOWER 2/3 MOO 14, BANGNA TRAD KM. 6.
Manufacturer CityBANGKAEW, BANGPLEE, SAMUTPRAKARN 10540
Manufacturer CountryTH
Manufacturer Postal10540
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIV
Generic NameINTEGRATED VALVE
Product CodeECX
Date Received2017-03-24
Model NumberM70610209
Lot Number201608
OperatorNURSE
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCEODEUX S.A.
Manufacturer Address24 ROUTE DE DIEKIRCH B.P. 19 L 19 L-7505 G.D. LINTGEN, LUXEMBORG LU


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-24

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