MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-10-25 for POSEY BED 8070 manufactured by J.t. Posey.
[58311426]
Evaluation of the returned canopy confirmed an open slider body on the right side window and a broken pull tab on the left side window. 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 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. As evidence of this, a separate pull tab was broken on the canopy. Of note, the canopy was (b)(6) at the time of the complaint report. 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 has been assessed, documented and acted upon as warranted. Manufacturer file #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58311427]
Customer reported the zipper teeth are damaged on the right side panel. It was later discovered during evaluation that the slider body is open. No patient incidents or injuries were reported. The exact date of event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00041 |
| MDR Report Key | 6055005 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-05 |
| Date Mfgr Received | 2016-10-05 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2016-10-25 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2016-10-25 |
| Returned To Mfg | 2016-09-29 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-10-25 |