MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for KEEPSAFE ESSENTIAL 8373 manufactured by Posey Products Llc.
[107232770]
(other) - the two alarms were not returned for evaluation and the serial number revealed the alarms are over 48 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. Manufacturer reference file #2017-02031, 2017-02032. Q1-2018 asr report (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107232771]
This report summarizes two malfunction events. The alarms do not sound when the magnet is detached. Q1 2018 asr report #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00034 |
| MDR Report Key | 7464257 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-04-26 |
| 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 | 2018-04-26 |
| Model Number | 8373 |
| Catalog Number | 8373 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK RD ARCADIA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |