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

Model Number 8070

Device Problem Material Frayed (1262)

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).

Event Description

Customer reported that the interior panel is frayed on the (finger guard) zipper pull, on both the left and right side panels.According to the nursing staff, patient was able to get fingers to the zipper and work it down allowing the patient to open the bed enclosure.A paperclip was found in the bed, however was not able to be determined if it was used to open the canopy.There was no harm or injury to the patient or staff.No gtin available.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 2530 linsay privado drive; ontario CA 91761
• Manufacturer Contact: chris rahn ; tidi products llc; 570 enterprise drvie; neenah, WI 54956 ; 9207514300
• MDR Report Key: 9795873
• MDR Text Key: 195134329
• Report Number: 2020362-2020-00021
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2020

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
• Device Lot Number: 2016031503
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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