MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-07 for POSEY BED 8070 manufactured by J.t. Posey.
[59288870]
Evaluation of the returned bed confirmed that one tooth from the right side panel was missing in addition to a 1 inch tear on the left side netting. All the issues listed were 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 put into use with a patient and should be returned to posey for servicing. If one zipper element is missing 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. If there are more than one consecutive zipper elements are missing it will not allow the zipper to be closed and will render the bed unusable. In order for a missing zipper element to potentially contribute to patient egress, the following must occur: the missing zipper element is not noticed, 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 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 missing zipper element. Of note, the canopy was 13 months old since its last service. Service issues are trended and reviewed by management on a monthly basis. As part of this monthly review, spikes, 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. Manufacturer reference file: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59288871]
Customer reported the slider and zipper teeth were damaged to the zipper located at the foot access panel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00047 |
| MDR Report Key | 6081134 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-11-07 |
| Date of Report | 2016-10-04 |
| Date Mfgr Received | 2016-10-04 |
| Device Manufacturer Date | 2014-09-04 |
| Date Added to Maude | 2016-11-07 |
| 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 | 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 FERROCARRILL NO. 16901. BO COLONIAL RIO TIJUANA,3RA. ETAP |
| Manufacturer City | TIJUANA, MEXICO 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 | 2016-11-07 |
| Returned To Mfg | 2016-10-27 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| Operator | OTHER CAREGIVERS |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-07 |