MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-14 for AUTO LOGIC PXB001DAR manufactured by Arjohuntleigh, A Branch Of Arjo Ltd Med Ab.
| Report Number | 3005619970-2020-00002 |
| MDR Report Key | 9710691 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2005-02-24 |
| Date Added to Maude | 2020-02-14 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG J1X5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X5Y5 |
| 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 | 2020-02-14 |
| Model Number | PXB001DAR |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB |
| Manufacturer Address | ARJOHUNTLEIGH HOUSE, HOUGHTON HALL BUSINESS PARK HOUGHTON REGIS, BEDFORDSHIRE LU5 5XF UK LU5 5XF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |