MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for SARA STEDY manufactured by Arjohuntleigh Polska Sp. Zo.o..
[135422455]
Sara stedy patient lift was being used when a caster came off and the patient almost fell. Threaded caster that became unscrewed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8309745 |
| MDR Report Key | 8309745 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-14 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-06 |
| Date Added to Maude | 2019-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SARA STEDY |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2019-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | 12625 WETMORE ROAD SUITE 308 SAN ANTONIO TX 78247 US 78247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |