MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for POSEY BED 8070 manufactured by J.t. Posey Company.
[41259316]
Evaluation of the returned bed confirmed that a zipper tooth on the left side panel is missing. Further evaluation also revealed zipper damage on the mold located on the left 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 put into use with a patient and should be returned to posey for servicing. 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
[41259317]
Customer reported the canopy has a broken zipper on the patient left side panel. The customer did not specify the date the issue was discovered. No patient or incident reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00015 |
| MDR Report Key | 5529083 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-15 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2015-01-21 |
| Date Added to Maude | 2016-03-28 |
| 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 | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | POSEY, S. DE R.L. DE C.V. |
| Manufacturer Street | AVE. FERROCARRIL NO. 16901. BO COLONIA RIO TIJUANA, 3RA. ETAP |
| Manufacturer City | TIJUANA 22664 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22664 |
| Single Use | 3 |
| 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 | 2016-03-28 |
| Returned To Mfg | 2016-03-04 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | N/A |
| 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 COMPANY |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-28 |