MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for INJ. OPTIV DH,SI W/OEM 844005 manufactured by Liebel-flarsheim.
[120540453]
This complaint was submitted via genesis in spanish. Translation is as follows: triggering the injection automatically, defect is intermittent, depending from where they touch the screen. Patient was connected, but there was no injury nor any damage. The customer reported that in the night, during the attempt of performing patency check by tightening the button for this function. The machine shooted injection of the contrast performing the injection protocol at the wrong moment. Reporter states that when performing customer training during some injection tests the same problem happened, providing the customer informed defect. Evaluated the defect and identified that the front cover is with internal reliever generating the contact in the start button even when we do not set the field corresponding to it. To solve the problem will be requested the front cover, so available the service will be done. The equipment is operational, but with this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00032 |
| MDR Report Key | 7872210 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-08-15 |
| Device Manufacturer Date | 2016-01-31 |
| Date Added to Maude | 2018-09-13 |
| 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 | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INJ. OPTIV DH,SI W/OEM |
| Generic Name | INJ. OPTIV DH,SI W/OEM |
| Product Code | IZQ |
| Date Received | 2018-09-13 |
| Model Number | 844005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |