MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-01-21 for POSEY BED 8070 manufactured by Posey Products Llc.
[133725697]
Evaluation of the canopy found one element damaged not allowing the zipper teeth to engage correctly. If one zipper element is missing / damaged in a patient accessible area, it can allow for the zipper to later be opened by separating the zipper at the location of the missing element. The user manual advises caregivers to apply direct pressure along the entire length of the zipper, to reveal the breach of an unsecured area. 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).
Patient Sequence No: 1, Text Type: N, H10
[133725698]
Customer reported the zipper on the right side panel is damaged. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00012 |
| MDR Report Key | 8265197 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-01-21 |
| Date of Report | 2019-01-07 |
| Date Mfgr Received | 2019-01-07 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2019-01-21 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2019-01-21 |
| Returned To Mfg | 2018-11-27 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| 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 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-21 |