MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for POSEY BED 8070 manufactured by Posey Products Llc.
[108146165]
Product will not be returned. This report is based solely on the information provided by the customer. An investigation of similar complaints found an event where the patient exited the bed. Investigation of the complaint found the product was not setup properly by the nurse. The unit was confirmed to have met product specification and no serious injury was associated with the complaint. 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 safe and effective use of the device. Posey beds are multi-use, serviceable items. As such, it is anticipated that the units may occasionally require repair, and as part of standard care the beds should be inspected prior to use. If damage is noted during these routine bed inspections, the unit should not be put into use with a patient and should be returned to posey for servicing. Service issues are trended and reviewed by management on a monthly basis. As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted. No corrective or preventative actions are necessary at this time. (b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[108146166]
Customer reported a patient exited the posey bed from the bottom foot side panel, on the left side of the bed and the patient fell. Additional information provided by customer stated patient did not suffer any injury. The date the incident occurred was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00030 |
| MDR Report Key | 7503635 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-19 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2018-05-10 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2018-05-10 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| 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 | 2018-05-10 |