ETHOX 4005H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-08 for ETHOX 4005H manufactured by Ethox Llc..

Event Text Entries

[92533091] The customer did not return the affected device and no lot number was provided. The customer's description indicates that the device could be pressurized but it would hold no pressure. After filing the complaint, the customer provided additional information which indicated that the bag was tested prior to use and presumably functioned as intended because a catheter was inserted in the patient before the bag "lost" pressure. It also stated that the staff is accustomed to these devices and followed the ifu and that they have not had any issues since. Based on the limited information provided, the investigator's conclusion is that this was an incident of the user not following the ifu and the device having a bad check valve. The device could be pressurized but the stopcock was not placed in the correct position to maintain pressure. The bad check valve was not able to maintain pressure as well as bags made with good check valves. This would explain why the device passed the pre-test and was placed in service but the did not adequately hold pressure during the procedure. Even with a bad check valve the device would have maintained pressure as intended if the stopcock had been placed in the "maintain" position.
Patient Sequence No: 1, Text Type: N, H10


[92533092] The customer alleges that "bag did not maintain pressure. Patient had loss of blood pressure and bag was deflated so catheter were blocked. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5


[120173577] The customer returned the affected device after the initial mdr was submitted on 11-8-2017. Functional and visual inspections were preformed and the product functioned as intended.
Patient Sequence No: 1, Text Type: N, H10


[120173578] The customer alleges that " bag did not maintain pressure. Patient had loss of blood pressure and bag was deflated so catheter were blocked. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1314417-2017-00002
MDR Report Key7009535
Report SourceDISTRIBUTOR
Date Received2017-11-08
Date of Report2017-10-11
Date of Event2017-09-14
Date Added to Maude2017-11-08
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 ContactMS. CARRIE FORTUNA
Manufacturer Street2710 NORTHRIDGE DR. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal49544
Manufacturer Phone6162598400
Manufacturer G1ETHOX LLC.
Manufacturer Street2710 NORTHRIDGE DR. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal Code49544
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETHOX
Generic NamePRESSURE INFUSION BAG
Product CodeKZD
Date Received2017-11-08
Model Number4005H
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerETHOX LLC.
Manufacturer Address2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-08

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