MAUDE Adverse Event Report: J.T. POSEY POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned bed confirmed that one tooth on the molding zipper located on the left side window is missing.No other damages or issues were found.The issue 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 put into use with a patient and should be returned to posey for servicing.One (1) missing zipper element (i.E., zipper ¿tooth¿) 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.Following the ifu and standard servicing protocols, the user can identify missing zipper teeth 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 missing zipper element cannot be confirmed, the canopy was approximately 60 months old, which means it was at or nearing the end of its useful life at the time of the complaint.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, spikes, trends and any excursion above the control limits for this failure mode will be assessed, documented an acted upon as warranted.Note: the instructions for use warns the user to never use the posey bed if there is damage to the canopy, damage to the access panels, or if the entire zipper does not close completely.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 reduce the risk of a fall or unassisted bed exit.(b)(4).

Event Description

Customer reported zipper on left side is missing pull tab and the stitching is separating.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): J.T. POSEY; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6257253
• MDR Text Key: 65029987
• Report Number: 2020362-2017-00002
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1