MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-27 for KEEPSAFE ESSENTIAL 8373 manufactured by Posey Products Llc.
[98847918]
Only one of the three alarms summarized in this report was returned for evaluation. The returned unit does not sound when the pull magnet is taken off from the magnet plate due to a defective reed switch that likely failed due to wear and tear. The alarm was over 24 months. The other two alarms not returned were over 24 months old. The reported issue of the alarm not sounding cannot be confirmed. With the information available and without the return of the alarm, it cannot be determined what the alleged failure was related to. Based on previous complaint investigations and the age of the alarms, the likely cause of the event is wear / tear or impact such as dropping or bumping. At this time, there is no evidence that a manufacturing non-conformity contributed to the complaint. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[98847919]
This report summarizes three malfunction events. The alarms have power but do not sound. (b)(4) asr report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00008 |
| MDR Report Key | 7223822 |
| Date Received | 2018-01-27 |
| Date of Report | 2018-01-23 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-01-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KEEPSAFE ESSENTIAL |
| Generic Name | FALL PREVENTION ALARM/SENSOR ATTACHED ONLY |
| Product Code | PJP |
| Date Received | 2018-01-27 |
| Model Number | 8373 |
| Catalog Number | 8373 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-27 |