MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309EL manufactured by Posey Products Llc.
[107203487]
The device was not returned for evaluation. 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. 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. 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. Q1 2018 asr report #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107203488]
This report summarizes one malfunction. Customer reported there was an incident that took place when a chair alarm did not activate. There was a patient fall and the patient's condition is unknown. Q1 2018 asr report #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00038 |
| MDR Report Key | 7464291 |
| 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 | ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-04-26 |
| Model Number | 8309EL |
| Catalog Number | 8309EL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 |