MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-13 for POSEY BED 8060 manufactured by Posey Products Llc.
[136135466]
Evaluation of the canopy confirmed the reported issue, the zipper teeth do not stay engaged while zipping up the canopy. The right side window zipper, was found to not engage the teeth correctly. If the zipper does not allow element closure in a patient accessible area, it can allow for the unintentional release of the patient, by separating the zipper at the location that the elements are not properly engaged. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136135467]
Customer reported the zipper teeth do no stay engaged while zipping up the canopy on the u side panel. 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 | 2020362-2019-00026 |
| MDR Report Key | 8336670 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-02-13 |
| 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 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2019-01-16 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| 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 | 2019-02-13 |