MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for SITTER ELITE 8345 manufactured by Posey Products, Llc.
[113024612]
Pt fell out bed. No injury. Bed alarm failed to alarm. Device was sent to our clinical engineering dept for evaluation. Device passed inspection and appears to be functioning correctly. Unable to duplicate the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7658083 |
| MDR Report Key | 7658083 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-26 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Reported to Mfgr | 2018-07-03 |
| Date Added to Maude | 2018-07-03 |
| 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 | RISK MANAGER |
| 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 | SITTER ELITE |
| Generic Name | BED ALARM |
| Product Code | KMI |
| Date Received | 2018-07-03 |
| Model Number | 8345 |
| Catalog Number | 8345 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS, LLC |
| Manufacturer Address | 5635 PECK RD. ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-03 |