MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for POSEY BED 8070 manufactured by Posey Product Llc.
[89403266]
(other): product was requested to be returned and has not been received for evaluation. Note: this report is based solely on the customer reported issue. At this time there is no evidence that a manufacturing non-conformity contributed to the complaint. The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe use and effectiveness of the canopy. The instructions for use (ifu) state "never use the bed if a zipper slider is bent open or damaged, or if the zipper cannot be zipped completely closed. Remove the patient from the damaged bed and exchange it for a posey bed in good working condition. Send the damaged posey bed in for repair. " manufacturer reference file no. (b)(4). Pending device return.
Patient Sequence No: 1, Text Type: N, H10
[89403267]
Customer reported the large window zipper separates when pressure is applied to the side panel. As a result the patient fell out of the canopy twice and bumped his head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00070 |
| MDR Report Key | 6901545 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-10-27 |
| Date of Event | 2016-10-01 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2013-11-17 |
| Date Added to Maude | 2017-09-28 |
| 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 PRODUCTS LLC 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2017-09-28 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCT LLC |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |