MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-22 for SINGLE-PATIENT USE CHAIR SENSOR PAD 8309 manufactured by Posey Products Llc.
[97888475]
Patient Sequence No: 1, Text Type: N, H10
[97888476]
Patient who underwent hip repair surgery after a fall with fracture late last year. Three days later, while in the hospital she was returned to her room from physical therapy. A staff member walked by her room and saw the patient on the floor. The posey chair alarm appeared to be on, but was not alarming. The staff did not remove this alarm pad or alarm box from service. The patient sustained a fracture to the hip and required surgery. She is currently in rehabilitation. We are unable to provide the product to the manufacturer for investigation. We have contacted the rep to make them aware. Manufacturer response for chair alarm, posey single patient use chair sensor pad (per site reporter). The rep will file a report to the posey manufacturer. Unfortunately we do not have the exact product for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7209428 |
| MDR Report Key | 7209428 |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-16 |
| Report Date | 2018-01-17 |
| Date Reported to FDA | 2018-01-17 |
| Date Reported to Mfgr | 2018-01-17 |
| Date Added to Maude | 2018-01-22 |
| 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 | 0 |
| 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 | 2018-01-22 |
| Model Number | 8309 |
| Catalog Number | 8309 |
| Device Availability | Y |
| Device Age | 4 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 432-434 INDUSTRIAL LN. BIRMINGHAM AL 35211 US 35211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2018-01-22 |