MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-08 for AUTO LOGIC 630004SV manufactured by Arjo (suzhou) Co., Ltd..
| Report Number | 1419652-2019-00188 |
| MDR Report Key | 8872888 |
| Date Received | 2019-08-08 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-05-03 |
| Date Facility Aware | 2019-07-12 |
| Report Date | 2019-08-08 |
| Date Reported to FDA | 2019-08-08 |
| Date Reported to Mfgr | 2019-08-08 |
| Date Added to Maude | 2019-08-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| 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 | 2019-08-08 |
| Model Number | 630004SV |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 MO |
| 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, 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-08 |