MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-14 for POSEY BED 8060 manufactured by Posey Products Llc.
[120397354]
Product is scheduled to be returned but have not been received in my 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 warning for the safe and effective use of the device. Therefore, no corrective or preventive actions are necessary. Communications to the customer advises against continuing use of the product if there is an associated product issue. 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 # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120397355]
Customer reported a patient was occupying a posey bed and was rolling back and forth in bed. The force of his rolling popped the zipper and he fell through the netting of the bed. Customer reported the patient suffered no injuries. Additional information provided by customer showed the device is still in use with the patient. The date the issue was discovered is unknown and no further details was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00125 |
| MDR Report Key | 7878883 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-14 |
| Date of Report | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-09-14 |
| 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 | POSEY BED 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2018-09-14 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| 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 | 2018-09-14 |