MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-03 for KEEPSAFE ESSENTIAL 8373 manufactured by Posey Products Llc.
[116065626]
The device was received with scratches on the exterior housing and the battery door missing. Evaluation of the unit found that when the unit is set to voice only and voice & tone modes, the pre-recorded voice message will not play? Only clicking sounds can be heard when weight is off the sensor pad due to a defective voice chip. Due to the age of the device it is likely that wear and tear may have contributed to the malfunction. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant. Manufacturer reference file# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116065627]
Customer did not specify the nature of the complaint. Evaluation found the alarm will not play the prerecorded message. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00102 |
| MDR Report Key | 7749445 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-03 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2013-06-24 |
| Date Added to Maude | 2018-08-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KEEPSAFE ESSENTIAL |
| Generic Name | FALL PREVENTION ALARM/SENSOR ATTACHED ONLY |
| Product Code | PJP |
| Date Received | 2018-08-03 |
| Returned To Mfg | 2018-07-09 |
| Model Number | 8373 |
| Catalog Number | 8373 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-03 |