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

Model Number 8060

Device Problem Material Separation (1562)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in my 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.Communications to the customer advises against continuing use of the product if there is an associated product issue.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.Manufacturer reference file # (b)(4).

Event Description

Customer reported a patient was occupying a posey bed and was rolling back and forth in bed.The force of his rolling popped the zipper and he fell through the netting of the bed.Customer reported the patient suffered no injuries.Additional information provided by customer showed the device is still in use with the patient.The date the issue was discovered is unknown and no further details was provided.

Event Description

Supplemental needed for additional information.

Manufacturer Narrative

Despite multiple attempts the product was not returned for analysis.Previous communication with the customer found the product was still in use after the event, in which the manufacturer advised against use in case of damages.Without the device, the reported issue or damages could not be confirmed and possible causes of the failure could not be determined.A historical review of all beds in the complaint database showed similar complaints in the last 2 years of the zipper not closing.Confirmed complaints of damages to the zipper did not lead to any patient injury.The posey bed is a serviceable, multiple use item.As such, some wear-and-tear is expected.The posey bed user manual is explicit in advising the customer to inspect for any missing or damaged components prior to use with a patient, and to not use the unit if any damage is found.The instructions states: warning, 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.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.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).

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 7878883
• MDR Text Key: 120397354
• Report Number: 2020362-2018-00125
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• PMA/PMN Number: K113355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1