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

Model Number 8060

Device Problem Misassembled During Installation (4049)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in for evaluation at the time of this report.Therefore, this report is based solely on the information provided by the customer.At this time there is not evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions for assembly 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 warranted.Manufacturer reference file # (b)(4).

Event Description

Customer reported that the vendor (agiliti) did not install the canopy correctly to the bed.This lead to the patient being able to get out of the bed.No damages or defects caused this incident.Customer provided information to complete troubleshooting.

• Brand Name: POSEY BED 8060
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 2530 privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise drvie; neenah, WI 91006 ; 9207514300
• MDR Report Key: 9460888
• MDR Text Key: 194315588
• Report Number: 2020362-2019-00236
• 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: 11/05/2019

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: 11/05/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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