MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-06 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309 manufactured by Posey Products Llc.
[138011598]
Customer returned alarm and sensor were evaluated and the products performed as expected. The investigation was unable to confirm any malfunction with the device. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The ifu states 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 or sensor if it does not activate each time weight is removed from the sensor, or if the chair belt sensor is unfastened. 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. Manufacturer reference file no. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138011599]
Customer reported the patient was sitting in a chair. When the patient released pressure from the sensor pad the alarm did not sound and the patient fell and as a result the customer fractured her leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00032 |
| MDR Report Key | 8396262 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-11 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-02-18 |
| Model Number | 8309 |
| Catalog Number | 8309 |
| Lot Number | 8304T038 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-06 |