MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-15 for POSEY BED 8070 manufactured by Posey Products Llc.
[97900506]
Evaluation results: evaluation of the return canopy found torn netting and the slider body open in a patient access area. The damaged slider was repaired and returned back to the customer for use. 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 be put into use with a patient and should be returned to posey for servicing. If the slider is opened it can potentially leave an unsecured area. Applying pressure directly to the unsecured area would cause the elements to separate, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper. If the elements do not have a secure fit when engaged the bed would be render unusable. In order for an open slider to potentially contribute to a patient egress, the following must occur: the open body slider is not noticed, the caregiver does not properly check the elements to ensure there is a secure fit prior to leaving the patient unattended, and the patient identifies the unsecured area, applies pressure against the elements and exits the bed. Following the instruction for use (ifu) and standard servicing protocols, the user can identify these issues prior to use and return the bed for repair. In this case, there was no impact or consequence to the patient and the canopy was returned for servicing when the zipper issues were identified. Although it cannot be confirmed, it is possible that routine wear-and-tear from repeated use contributed to the open slider body. Of note, the canopy was 6 months old since its last service. Service issues are trended and reviewed by management on a monthly basis. As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted. No corrective or preventative actions are necessary at this time. Note: the ifu warns the user to never use the posey bed if there is damage to the canopy, damage to the accuses panels, or if the entire zipper does not close completely. A 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 help reduce the risk of a fall or unassisted bed exit. Manufacturer reference file #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97900507]
Customer reported the netting to the canopy is torn on the head access panel. The date the issue was discovered is unknown and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00003 |
| MDR Report Key | 7192510 |
| Date Received | 2018-01-15 |
| Date of Report | 2018-01-08 |
| Date Mfgr Received | 2018-01-08 |
| Device Manufacturer Date | 2016-12-28 |
| Date Added to Maude | 2018-01-15 |
| 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 | 0 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-03 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| Device Availability | R |
| 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 | 2018-01-15 |