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..
[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
| Report Number | 1314417-2017-00002 |
| MDR Report Key | 7009535 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-08 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-09-14 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | ETHOX LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHOX |
| Generic Name | PRESSURE INFUSION BAG |
| Product Code | KZD |
| Date Received | 2017-11-08 |
| Model Number | 4005H |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHOX LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |