MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY BED 8060; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8060

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Inspection found a zipper element missing, which can allow for the unintentional opening of the canopy window.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.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.Instructions for use(ifu) were reviewed and found to provide adequate instructions and warning for safe and effective use of the device.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

Customer reported the canopies have zippers that are damaged.Customer provided limited information.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7917190
• MDR Text Key: 122008749
• Report Number: 2020362-2018-00135
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2018

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: No Information
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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