MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for AUTO LOGIC manufactured by Getinge (suzhou) Co., Ltd..
[131773863]
(b)(4). Additional information will be provided upon the investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10
[131773864]
Arjo was notified by a customer that a patient fell from the bed "while was sleep". It was indicated that the safety sides were raised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619970-2018-00019 |
| MDR Report Key | 8159588 |
| Date Received | 2018-12-13 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-08-19 |
| Date Facility Aware | 2018-11-19 |
| Report Date | 2019-01-31 |
| Date Reported to FDA | 2019-01-31 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-13 |
| 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 | MS KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | GETINGE (SUZHOU) CO., LTD. |
| Manufacturer Street | NO. 158 FANGZHOU ROAD, |
| Manufacturer City | JIANGSU, SUZHOU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUTO LOGIC |
| Generic Name | CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE |
| Product Code | FBM |
| Date Received | 2018-12-13 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE (SUZHOU) CO., LTD. |
| Manufacturer Address | NO. 158 FANGZHOU ROAD, JIANGSU, SUZHOU 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-13 |