MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY 8309 manufactured by Posey Products Llc.
[105517932]
Product was discarded and will not be returned for analysis. This report is based solely on the information provided by the customer (user facility report (b)(4)). Confirmation of customer's complaint and the root cause could not be determined. Based on previous complaint investigations of no sound or product 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 issues. 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 ifu states "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. (b)(4). Product had been discarded.
Patient Sequence No: 1, Text Type: N, H10
[105517933]
Customer reported the patient originally underwent hip repair surgery after a fall with fracture late last year. Three days later, while in the hospital, she was returned to her room from physical therapy. A staff member walked by her room and saw the patient on the floor. The posey chair alarm appeared to be on, but was not alarming. The staff did not remove this alarm pad or alarm box from service. The patient sustained a fracture to the hip and required surgery. She is currently in rehabilitation. Customer is unable to provide the product to posey for investigation. The date of the incident was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00024 |
| MDR Report Key | 7431073 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-22 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-13 |
| 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 | 0 |
| Brand Name | ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-04-13 |
| Model Number | 8309 |
| Catalog Number | 8309 |
| Lot Number | UNK |
| Operator | NURSE |
| 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 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2018-04-13 |