MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-28 for AGS manufactured by Getinge Disinfection Ab.
[137380477]
(b)(4). The issue is being investigated by manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[137380478]
On 13th february, 2019 we became aware of an incident with loading equipment device? Ags (air glide system) used together with 86-series washer disinfector. As it was stated, staff member went to adjust basket that was stuck on ags. The unloading hook slipped rapidly and injured her hand. The injury sustained was classified as serious one. Although the ags device is not registered as medical device, when the event occurred it was being used with a medical device as a system, therefore we decided to report this issue to competent authority.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2019-00003 |
| MDR Report Key | 8377510 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-28 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-02-12 |
| Date Facility Aware | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2012-03-16 |
| Date Added to Maude | 2019-02-28 |
| 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 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGS |
| Generic Name | STERILIZER AUTOMATED LOADING SYSTEM |
| Product Code | PEC |
| Date Received | 2019-02-28 |
| 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 KRONOBERGS IAN [SE-07] VAXJO 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-28 |