MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-28 for ALARM SENSOR, BED SENSOR PAD 6MTH 8307 manufactured by Posey Products Llc.
[118549411]
Product is scheduled to be returned but have not been received in by the manufacturer at the time of this report. Therefore, this report is based solely on the information provided by the customer. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. The ifu states, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended. 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. In addition, the time delay option is to allow some patient movement without setting off alarm, but still give sufficient warning when patient attempts to get off of a sensor pad. This is especially useful when connected to the nurse call system to minimize false alarms. The ifu states, assess patient frequently to ensure that a time delay is appropriate. Set the delay at zero (0) with patients at extreme risk of injury from a fall associated with an unassisted bed, chair or toilet exit. Therefore, no corrective or preventive 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). No product returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[118549412]
Customer reported that when pressure is taken off the sensor the alarm does not sound. The end user is using the alarm with a chair sensor. The date the issue was discovered is unknown and no patient incident or injury was reported. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00104 |
| MDR Report Key | 7824778 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-28 |
| Date of Report | 2018-09-24 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-08-28 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARM SENSOR, BED SENSOR PAD 6MTH |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-08-28 |
| Model Number | 8307 |
| Catalog Number | 8307 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-28 |