MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-22 for POSEY BED 8060 manufactured by Posey Products Llc.
[92766952]
Product is scheduled to be returned but have not been received in by manufacturer at the time of this report. Therefore, this report is based solely on the information provided by the customer. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. 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
[92766953]
Customer reported the nurse saw the patient sliding out of the bed on the security camera and was unable to get to the patient in time to stop him/her from falling to the floor. The nurse did not place the safety zipper in the correct position allowing the patient to get their hands through the opening and unzip the canopy enough to crawl out. It was stated the patient slid onto the floor, possibly injuring a previously fractured arm. The date the incident was not known.
Patient Sequence No: 1, Text Type: D, B5
[110083962]
The product was received and analyzed. The product was found to have met specifications with no product non-conformances found. During the investigation it was noted that the accounts of the patient occurrence are consistent with the bed not being properly secured and closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110083963]
Additional information is provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00083 |
| MDR Report Key | 7053036 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-22 |
| Date of Report | 2017-12-28 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2016-05-24 |
| Date Added to Maude | 2017-11-22 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2017-11-22 |
| Returned To Mfg | 2017-11-28 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| Lot Number | NA |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-22 |