MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for POSEY BED 8060 manufactured by Posey Products Llc.
[86602023]
Evaluation results : evaluation of the returned canopy found an open slider in a patient access area which could allow the unintentional patient escape. In addition, there was a 1/2 inch tear on the front side window. If the zipper slider body is bent open (i. E. , the mouth is wider than manufacturing specifications) it can prevent the slider from properly engaging the zipper teeth. In areas where the slider engages the teeth, the zipper is secure and cannot be opened. However, if the teeth do not engage it can potentially leave an unsecured area. Applying pressure directly to the unsecured area will reveal the breach, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper. In order for an open slider to potentially contribute to patient egress, the following must occur: the slider does not engage the teeth, the caregiver does not properly check the zipper prior to leaving the patient unattended, and the patient identifies the unsecured area and exits the bed. Following the ifu and standard servicing protocols, the user can identify any open sliders 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 the cause of the open slider cannot be confirmed, it is possible that an excessive amount of force was applied to the pull tab, which could have bent the slider body open. 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. Manufacture reference file # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86602024]
Customer reported the canopy has a damaged zipper. The date the issue was discovered is unknown and there was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00069 |
| MDR Report Key | 6861761 |
| Date Received | 2017-09-13 |
| Date of Report | 2017-08-25 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-09-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | POSEY S DE RL DE CV |
| Manufacturer Street | CAM. ANTIGUA A TECATE #16760 I COLONIA NI |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22120 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY BED 8060 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2017-09-13 |
| Returned To Mfg | 2017-08-25 |
| Model Number | 8060 |
| Catalog Number | 8060 |
| 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 ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-13 |