MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for POSEY BED 8060 manufactured by Posey Products Llc.
[83969558]
Conclusion codes: inspection found a zipper element is missing, which can allow for the unintentional opening of the canopy window. Applying pressure directly to the unsecured area will reveal the breach, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper. In addition a 1 inch netting tear was found on the patient access front side window. 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. Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. 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)
Patient Sequence No: 1, Text Type: N, H10
[83969559]
Customer reported the netting to the canopy is torn on the left side panel. The date the issue was discovered is unknown and no patient incident was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00067 |
| MDR Report Key | 6825838 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2017-08-28 |
| 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 | 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | POSEY S DE RL DE CV |
| Manufacturer Street | CAM. ANTIGUA A TECATE #16760 I COLONIA NI |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22120 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY BED 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2017-08-28 |
| Returned To Mfg | 2017-08-02 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| Lot Number | 2016080108 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-28 |