MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-25 for POSEY BED 8070 manufactured by J. T. Posey Co..
[5477050]
Customer reported multiple tears at the foot end of the canopy. Customer did not provide a date when the issue was discovered. No patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12945615]
Results: evaluation of the returned product found one element missing from the molding zipper of the left window and 8 inches of the material unraveling on the leg of the foot panel side. One element missing would allow the zipper to initially close, but can separate at the location of the missing element if sufficient pressure is applied. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2015-00032 |
| MDR Report Key | 4552834 |
| Report Source | 08 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-16 |
| Date Mfgr Received | 2015-02-16 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2015-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROXANA KOUSSA |
| Manufacturer Street | 5635 PECK RD. |
| 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. BODEGA 64 COLONIA RI O TIJUANA, 3RA. ETAPA |
| 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 |
| Product Code | OYS |
| Date Received | 2015-02-25 |
| Returned To Mfg | 2015-02-12 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-25 |