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

Model Number 8070

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

(other): product was requested to be returned and has not been received for evaluation.Note: this report is based solely on the customer reported issue.At this time there is no evidence that a manufacturing non-conformity contributed to the complaint.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe use and effectiveness of the canopy.The instructions for use (ifu) state "never use the bed if a zipper slider is bent open or damaged, or if the zipper cannot be zipped completely closed.Remove the patient from the damaged bed and exchange it for a posey bed in good working condition.Send the damaged posey bed in for repair." manufacturer reference file no.(b)(4).Pending device return.

Event Description

Customer reported the large window zipper separates when pressure is applied to the side panel.As a result the patient fell out of the canopy twice and bumped his head.

Manufacturer Narrative

Inspection of the unit found an open zipper slider on the patient access window.In addition, the pull tab was missing on the left window side.A missing pull tab would render the bed unusable as is would not allow the side window to properly close.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.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.(b)(4).

Event Description

Supplemental required for evaluation results.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCT LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey products llc; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6901545
• MDR Text Key: 89403266
• Report Number: 2020362-2017-00070
• 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: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2013
• 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
• Patient Age: 18 YR