MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-27 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309 manufactured by Posey Products Llc.
[98848079]
.without the return of the device, the complaint cannot be confirmed . based on previous complaint investigations of no sound or not sounding when it should, it can be speculated that a damaged rj11 clip or folds and creases on the sensor, may have contributed to the reported issue . 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 warranted . manufacturer reference file # . product not returned .
Patient Sequence No: 1, Text Type: N, H10
[98848080]
This report summarizes one malfunction event. This report is for a sensor that is not sending a signal to the alarm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00007 |
| MDR Report Key | 7223820 |
| Date Received | 2018-01-27 |
| Date of Report | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| 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 | ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-01-27 |
| Model Number | 8309 |
| Catalog Number | 8309 |
| 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 | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-27 |