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

Model Number 8070

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: evaluation of the returned product found one element damaged on the molding zipper (a patient access area) which could allow the unintentional release of a patient.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 warnings 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 via email there is a broken zipper.Limited information provided.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS; 2530 lindsay privado drive; unit a; ontario CA 91761
• MDR Report Key: 12528140
• MDR Text Key: 280537006
• Report Number: 2020362-2021-00060
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• PMA/PMN Number: K113357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Device Lot Number: 2020012826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1