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

Model Number 8060

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Upon review this submission was not received by the fda, and is being resubmitted.The injury was reported in conjunction with the use of this device.The cause of the injury is unable to be confirmed as reported.The product was not returned for inspection.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\tidi for servicing.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warning 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 canopy has a tear in the mattress envelope in the corner.The reporter advised that the patient broke their finger, however they are not certain if this injury occured while the patient was in the bed.They are unable to confirm the cause of injury.

• Brand Name: POSEY BED 8060
• Type of Device: PATEINT BED WITH CANOPY / RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah,
• MDR Report Key: 9330523
• MDR Text Key: 166664146
• Report Number: 2020362-2019-00214
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Device Lot Number: 2016093003
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2016
• 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
• Patient Outcome(s): Other