MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-08-07 for KEEPSAFE ESSENTIAL 8373 manufactured by Posey Products Llc.
[116391301]
Evaluation results: the device was returned and analyzed. The device was received in with no physical damages noted and powered on with no issue. However functional testing showed the device did not sound when in use with the pull magnet. Upon opening the device, the cause for the failure was a faulty speaker, where the speaker impedance was out of range. This loss of functionality would result in the alarm? S failure to alert the caregiver of a patient exit and could contribute to a patient incident. Being that the device had been in use for over a year, it is likely normal wear and tear that contributed to the reported issue. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. The ifu states "to reduce the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended. If the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor. Do not use the alarm, sensor or magnet if it does not activate each time weight is removed from the sensor, the chair belt sensor is unfastened, or magnet is removed from face plate. " 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
[116391302]
Customer stated the device is no longer working. Evaluation results found the unit has power but does not sound. 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 | 2020362-2018-00070 |
| MDR Report Key | 7759514 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-08-07 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2017-06-26 |
| Date Added to Maude | 2018-08-07 |
| 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 | 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KEEPSAFE ESSENTIAL |
| Generic Name | FALL PREVENTION ALARM/SENSOR ATTACHED ONLY |
| Product Code | PJP |
| Date Received | 2018-08-07 |
| Returned To Mfg | 2018-07-19 |
| 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 RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-07 |