MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-01-17 for POSEY BED 8070 manufactured by J.t. Posey.
[65029987]
Evaluation of the returned bed confirmed that one tooth on the molding zipper located on the left side window is missing. No other damages or issues were found. The issue was repaired and returned back to the customer for use. 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 put into use with a patient and should be returned to posey for servicing. One (1) missing zipper element (i. E. , zipper? Tooth? ) 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. Following the ifu and standard servicing protocols, the user can identify missing zipper teeth prior to use and return the bed for repair. In this case, there was no impact or consequence to the patient and the canopy was returned for servicing when the zipper issues were identified. Although the cause of missing zipper element cannot be confirmed, the canopy was approximately 60 months old, which means it was at or nearing the end of its useful life at the time of the complaint. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, spikes, trends and any excursion above the control limits for this failure mode will be assessed, documented an acted upon as warranted. Note: the instructions for use warns the user to never use the posey bed if there is damage to the canopy, damage to the access panels, or if the entire zipper does not close completely. Failure to follow this warning may lead to serious injury or death from a fall. Always check the canopy and make sure the entire zipper is completely closed before leaving the patient alone to reduce the risk of a fall or unassisted bed exit. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65029988]
Customer reported zipper on left side is missing pull tab and the stitching is separating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00002 |
| MDR Report Key | 6257253 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-01-17 |
| Date of Report | 2016-12-28 |
| Date Mfgr Received | 2016-12-28 |
| Device Manufacturer Date | 2012-01-06 |
| Date Added to Maude | 2017-01-17 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2017-01-17 |
| Returned To Mfg | 2016-12-22 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER CAREGIVERS |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-17 |