MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for SINGLE-PATIENT USE CHAIR SENSOR PAD 8309EL manufactured by Posey Products Llc.
[110916217]
Patient Sequence No: 1, Text Type: N, H10
[110916218]
Patient was sitting in chair, needed to go to restroom, and did not call for assistance. Posey chair alarm did not sound even though was on. Patient sustained a fall with injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7595890 |
| MDR Report Key | 7595890 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-05-15 |
| Report Date | 2018-05-21 |
| Date Reported to FDA | 2018-05-21 |
| Date Reported to Mfgr | 2018-05-21 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| 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 | SINGLE-PATIENT USE CHAIR SENSOR PAD |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-06-13 |
| Catalog Number | 8309EL |
| ID Number | L9378M REV D 052815 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-13 |