MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: evaluation of the return canopy found torn netting and the slider body open in a patient access area.The damaged slider 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 be put into use with a patient and should be returned to posey for servicing.If the slider is opened it can potentially leave an unsecured area.Applying pressure directly to the unsecured area would cause the elements to separate, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper.If the elements do not have a secure fit when engaged the bed would be render unusable.In order for an open slider to potentially contribute to a patient egress, the following must occur: the open body slider is not noticed, the caregiver does not properly check the elements to ensure there is a secure fit prior to leaving the patient unattended, and the patient identifies the unsecured area, applies pressure against the elements and exits the bed.Following the instruction for use (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 open slider body.Of note, the canopy was 6 months old since its last service.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: the ifu warns the user to never use the posey bed if there is damage to the canopy, damage to the accuses panels, or if the entire zipper does not close completely.A 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 help reduce the risk of a fall or unassisted bed exit.Manufacturer reference file #(b)(4).

Event Description

Customer reported the netting to the canopy is torn on the head access panel.The date the issue was discovered is unknown and no patient injury was reported.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7192510
• MDR Text Key: 97900506
• Report Number: 2020362-2018-00003
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1