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 2018-02-08 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309 manufactured by Posey Products Llc.
[99535092]
Associated with medwatch # 2020362-2018-00006. Product was received and analyzed. Analysis found the product is functioning normally as a system in triggering the alarm when there is no weight on the sensor pad and silences when weight is applied to the sensor pad. The sensor pad passed both the visual and functional testings and we were unable to replicate customer's complaint of the product not sending the proper signal to the alarm. At this 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 warning 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99535093]
Customer reported during use of the alarm, the unit did not sound when the patient's weight was removed from the sensor pad. Following the patient exit, the patient fell and hit his/her head. X-rays were needed and surgery was performed for evacuation of a hematoma. The alarm and sensor pad were tested by sale representative and both products were found to be working as designed. Event date is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00014 |
| MDR Report Key | 7257795 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2017-08-30 |
| Date Added to Maude | 2018-02-08 |
| 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 | 2018-02-08 |
| Returned To Mfg | 2018-01-31 |
| Model Number | 8309 |
| Catalog Number | 8309 |
| Lot Number | 7242T079 |
| Operator | NURSE |
| 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 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-08 |