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

Model Number 8070

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Conclusion: evaluation of the returned product found one element missing on the molding zipper (a patient access area) which could allow the unintentional release of a patient.Applying pressure directly to the unsecured area will reveal the breach, which is why the user manual advises caregivers to apply direct pressure along the entire length of the zipper.In addition, there was a one inch tear on the head side leg and multiple areas of unraveling on the head and foot side legs.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 be put into use with a patient and should be returned to posey for servicing.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Service issues are trended and reviewed by management on a monthly basis.As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.(b)(4).

Event Description

Customer reported the zipper on the left side panel is damaged.The date the issue was discovered is unknown.No patient injury was reported.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer (Section G): POSEY S DE RL DE CV; cam. antigua a tecate #16760 i; colonia niños heroes este; tijuana, baja california 22120 ; MX 22120
• Manufacturer Contact: william hincy ; posey products llc; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7327787
• MDR Text Key: 102201072
• Report Number: 2020362-2018-00019
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2018

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: Nurse
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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