MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for FSC manufactured by Getinge Disinfection Ab.
[139198732]
(b)(4). The issue is still being investigated by manufacturing site. We are aware that this is past the 30 day deadline for reporting. We have reminded the complaint handler to review fda reporting guidelines in order to prevent this from happening again.
Patient Sequence No: 1, Text Type: N, H10
[139198733]
On (b)(6) 2018 we became aware of an issue with fsc - loading equipment. The device was used together with the medical device as a system. As it was stated, the carts were falling off from the device. There was no injury reported; however, we decided to report the issue based on the potential as carts falling off may lead to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2019-00008 |
| MDR Report Key | 8428044 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-05-27 |
| Date of Event | 2018-06-30 |
| Date Facility Aware | 2018-06-30 |
| Report Date | 2019-03-18 |
| Date Reported to FDA | 2019-03-18 |
| Date Mfgr Received | 2018-06-30 |
| Date Added to Maude | 2019-03-18 |
| 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 Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FSC |
| Generic Name | STERILIZER AUTOMATED LOADING SYSTEM |
| Product Code | PEC |
| Date Received | 2019-03-18 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |