MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-11 for POSEY BED 8070 manufactured by J.t. Posey Company.
[57043407]
Additional information has been requested but has not yet been received. Note; this submission is based solely on the user facility's reported issue. Note: the instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. Specifically checking the zipper, the ifu warn users to, "never leave the patients bedside until all access panel zippers are completely closed. Quick-release buckles be connected and closed on all four access panels before the patient is left alone. " (b)(4). No alleged malfunction.
Patient Sequence No: 1, Text Type: N, H10
[57043408]
Customer mentioned that a patient fell out of the canopy and fractured their elbow. Customer was unable to provide any other information. Customer requested a sign that reminds staff to make sure that the canopy window is zipped closed. The exact date of event is unknown.
Patient Sequence No: 1, Text Type: D, B5
[58270823]
Customer provided additional information regarding the incident occurring during a shift change. The patient had both a sitter and respiratory therapist. The respiratory therapist turned their back to obtain medication, when the patient rolled towards the floor, falling on their side and landing on their elbow. The enclosure was not been zipped up, allowing the patient to be able to fall out. The patient's injury was reported as "soft tissue swelling at the olecranon process and proximal medial forearm. A subtle linear density was seen paralleling the cortex of the olecranon process and may represent small chip fx. " the unit director was contacted regarding the patients outcome. Unit director confirmed, "no surgery was indicated and was discharged to a skilled nursing facility (snf). The cause of the fall was not from a manufacturing standpoint or device failure. " at this time, due to additional information received, there was no malfunction confirmed and the allegations appear to be pointed towards the fact that the enclosure was not zipped up. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. Specifically checking the zipper, the ifu warn users to, "never leave the patients bedside until all access panel zippers are completely closed. Quick-release buckles be connected and closed on all four access panels before the patient is left alone. " manufacturer record #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58270824]
Supplemental submission based on additional information received regarding patient. The exact date of event remains unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00034 |
| MDR Report Key | 6019397 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-11 |
| Date of Report | 2016-10-18 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-10-11 |
| 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 |
| 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 | 2016-10-11 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-11 |