MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for POSEY BED 8070 manufactured by Posey Products Llc.
[108486274]
Evaluation of the returned canopy found an open slider in a patient access area, which could allow the unintentional patient escape. In addition, there was a broken pull tab on the left side window. If the zipper slider body is bent open (i. E. , the mouth is wider than manufacturing specification) it can prevent the slider from properly engaging the zipper teeth. In areas where the slider engages the teeth, the zipper is secure and cannot be opened. However, if the teeth do not engage it can potentially leave an unsecured area. 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. 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. The instructions for use (ifu) state "never use the bed if a zipper slider is bent open or damaged, or if the zipper cannot be zipped completely closed. Remove the patient from the damaged bed and exchange for a posey bed in good working condition. Return the damaged posey bed for repair. " 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
[108486275]
Customer reported the netting to the canopy is torn and the canopy has a damaged zipper. The date the issue was discovered is not known and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00040 |
| MDR Report Key | 7513073 |
| Date Received | 2018-05-14 |
| Date of Report | 2018-04-26 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-12-11 |
| Date Added to Maude | 2018-05-14 |
| 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 | 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 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-04-06 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| 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 | 2018-05-14 |