MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-27 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309EL manufactured by Posey Products Llc.
[115292389]
Reference associated medwatch #2020362-2018-00065. Customer stated will not be returning product for analysis and this report is based solely on the information provided by the customer. Without the return of the device, the complaint cannot be confirmed. Based on previous complaint investigations, it can be speculated that either damage to the sensor pad or rj11 clip, folds and creases on the sensor, moisture and wear and tear may have 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 were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. The instructions for use state "always check sensor pads when connecting them to a posey alarm. You can check a sensor pad by attaching it to the sensor input on the alarm, activating the alarm and placing pressure on the sensor pad. When the pressure is released, the alarm should sound. Repeat this pressure/release test in several different areas along the entire length of the sensor pad to ensure entire sensor pad functions properly. If the alarm and/or sensor pad do not function properly, remove the alarm and sensor pad from service and replace them with a properly functioning alarm and/or sensor pad. Do not use the alarm or sensor pad if it does not activate each time weight is removed from the sensor pad. " 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 warranted. Manufacturer reference file #(b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[115292391]
Customer reported while the patient was in use with the posey alarm and the chair pad sensor, the alarm did not sound when the patients weight was removed from the sensor. The patient was attempting to use the restroom and did not call for assistance. The patient fell out of the wheel chair and fractured his/her hip. The patient underwent surgery to repair the fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00066 |
| MDR Report Key | 7728483 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-27 |
| Date of Report | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Date Added to Maude | 2018-07-27 |
| 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 | 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-07-27 |
| Model Number | 8309EL |
| Catalog Number | 8309EL |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-27 |