MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for ALARM SENSOR, 30-DAY BED SENSOR PAD 8283 manufactured by Posey Products Llc.
[112994255]
Reference medwatches 2020362-2018-00045 and 2020362-2018-00047 for associated products. Product is scheduled to be returned but have not been received in by manufacturing 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 were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. 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
[112994256]
Customer reported the alarm did not sound when the patients weight was removed from the sensor pad. As a result the patient fell out of the bed and was found on the floor by the nurse. The patient was taken to hospital and received a cat scan. It was found that she had bleeding in her head. The date the injury occurred was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00046 |
| MDR Report Key | 7657228 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-17 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2018-07-02 |
| 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, 30-DAY BED SENSOR PAD |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-07-02 |
| Returned To Mfg | 2018-07-09 |
| Model Number | 8283 |
| Catalog Number | 8283 |
| Lot Number | 8052T050 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-02 |