MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-14 for AGS manufactured by Getinge Disinfection Ab.
[138795829]
(b)(4). 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. The issue is still being investigated by manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[138795830]
On (b)(6)2018 we became aware of an issue with ags- loading equipment outside machine which was used together with 8666 washer disinfector. As it was stated, the end stop was jammed intermittently which nearly caused the wash cart to fall over. There was no injury reported however we decided to report the issue based on the potential as falling cart may lead to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2019-00007 |
| MDR Report Key | 8420367 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2019-05-27 |
| Date Facility Aware | 2018-09-12 |
| Report Date | 2019-05-02 |
| Date Reported to FDA | 2019-05-02 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2007-06-21 |
| Date Added to Maude | 2019-03-14 |
| 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 | MR DENNIS GENITO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097515 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO, 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGS |
| Generic Name | AGS |
| Product Code | PEC |
| Date Received | 2019-03-14 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] VAXJO, 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |