MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-08-14 for POSEY BED 8070 manufactured by Posey Company.
[23123342]
Results: evaluation of the returned product found an open zipper slider on the left side window of a patient access area which would not allow proper element closure. Delamination of the mattress envelope on the right side panel was also noted. 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 put into use with a patient and should be returned to posey for servicing. 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, the canopy was approximately 40 months old and there was evidence of improper laundering (material delamination). 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: instructions for use states: never use the posey bed if there is damage to the canopy, access panels or zippers. A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall. Always check the canopy and the zippers before leaving the patient alone to help reduce the risk of a fall or unassisted bed exit. Never rip the panels open, as this will damage the zipper slider, preventing the zipper from closing completely. Before leaving the patient alone, apply pressure with your hands along the entire length of the zipper to make sure the panel is completely closed and that there are no gaps or openings along the entire length of each zipper. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23123343]
Customer reported damage to the zipper located on the left side panel. No patient incident or injury was reported and the customer did not know when the issue was discovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2015-00060 |
| MDR Report Key | 5005662 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-05 |
| Date Mfgr Received | 2015-08-05 |
| Device Manufacturer Date | 2012-04-09 |
| Date Added to Maude | 2015-08-14 |
| 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 | MR. WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | POSEY, S. DE R.L. DE C.V. |
| Manufacturer Street | AVE. FERROCARRIL NO. 16901. BO COLONIA RIO TIJUANA, 3RA. ETAP |
| Manufacturer City | TIJUANA 22664 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22664 |
| 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 | 2015-08-14 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | 2012040905 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |