MAUDE Adverse Event Report: J.T. POSEY COMPANY POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned bed confirmed that a zipper tooth on the left side panel is missing.Further evaluation also revealed zipper damage on the mold located on the left side window.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 put into use with a patient and should be returned to posey for servicing.The instructions for use warns the user to never use the posey bed if there is damage to the canopy, damage to the access panels, or if the entire zipper does not close completely.Failure to follow this warning may lead to serious injury or death from a fall.Always check the canopy and make sure the entire zipper is completely closed before leaving the patient alone to reduce the risk of a fall or unassisted bed exit.(b)(4).

Event Description

Customer reported the canopy has a broken zipper on the patient left side panel.The customer did not specify the date the issue was discovered.No patient or incident reported.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): J.T. POSEY COMPANY; 5635 peck rd; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana 22664 ; MX 22664
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 5529083
• MDR Text Key: 41259316
• Report Number: 2020362-2016-00015
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2016

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: Other Caregivers
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1