MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-08 for AUTO LOGIC PXB001DAR manufactured by Arjo (suzhou) Co.,ltd..
| Report Number | 3005619970-2020-00001 |
| MDR Report Key | 9563273 |
| Report Source | FOREIGN |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2020-01-08 |
| 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 | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJO (SUZHOU) CO.,LTD. |
| Manufacturer Street | NO. 158 FANGZHOU ROAD, SIP |
| Manufacturer City | SUZHOU, JIANGSU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO LOGIC |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | FNM |
| Date Received | 2020-01-08 |
| Model Number | PXB001DAR |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO (SUZHOU) CO.,LTD. |
| Manufacturer Address | NO. 158 FANGZHOU ROAD, SIP SUZHOU, JIANGSU 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |