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

Model Number 8070

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in by manufacturing at the time of this report.Therefore, this report is based solely on the information provided by the customer.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventive actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).Expected but have not returned yet.

Event Description

Customer reported the patient was able to get out of the canopy.The patient split the zippers from the inside on just one side of the canopy.The outside buckles were locked with the zippers properly.The customer was advised not to use the bed and to get a new rental.The date the issue was discovered is unknown and no patient incident or injury was reported.No additional information was provided at the time of this report.

Manufacturer Narrative

The device was received in and inspected by manufacturer.Analysis of the product found it met specification and manufacturing was unable to confirm the reported issue with the zippers.The zippers were found to be engaged and no separation behind the zipper slider was noted.No evidence of any damage to the zipper chain or sliders were observed.During testing, the zipper opened and closed properly.The zippers functioned smoothly with no signs of damage or separation.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu provide warnings to, never use the posey bed if there is damage to the canopy, access panels or zippers.A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall.Always check the canopy and the zippers before leaving the patient unattended to help reduce the risk of a fall or unassisted bed exit.Never leave a patient unattended if the zippers do not close securely, there are holes in the canopy or netting, the foam padding covering the metal frame is damaged or missing, or the frame is damaged.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant.(b)(4).

Event Description

Supplemental required for additional information.

Manufacturer Narrative

The device was visually inspected and it was noted the product was missing pull tabs from 2 zippers.Loose stitching was also observed at the the mattress enclosure of the canopy.The posey beds are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair.The described findings are known normal wear and tear of the product and is not likely to have contributed to the issue described in this event.As part of the standard care, the user guide encourages annual servicing of the bed and or when damages are noted.Manufacturer reference file #2018-01300.

Event Description

Supplemental needed for correction.

• 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
• MDR Report Key: 7920824
• MDR Text Key: 122152171
• Report Number: 2020362-2018-00131
• 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: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

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: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/22/2018; 10/26/2018
• Supplement Dates FDA Received: 10/25/2018; 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1