|
Model Number 6027R |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Fall (1848)
|
Event Date 04/21/2018 |
Event Type
Injury
|
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 no evidence that a manufacturing non-conformity contributed to the reported complaint and the posey mats 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 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 a nurse slipped and fell while using one of the posey fall mats.The employee slipped and fell due to a liquid spill that got under the mat and the mat slid when the employee stepped on it.The nurse twisted her left knee but have not sought any medical treatment at the time of this report.No other information is available.
|
|
Manufacturer Narrative
|
Additional information provided by the customer confirmed the product part number.Customer also confirmed the product will not be returning, therefore, this report is based solely on the information provided by the customer.An investigation of similar complaints found two other events where it was reported the nurse fell when the floor cushion slipped.Customer confirmed there was no product non-conformity.Also confirmed the customer is aware of the instruction for use's recommendation of cleaning up spills to avoid the mat slipping.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The ifu states "inform resident and staff to take care when stepping on or off of the cushion to avoid tripping.Follow your facility¿s procedures for cleaning spills in patient care areas.Do not place floor cushions on or around damp or wet areas.Clean spills on, around or under floor cushions.Liquids under floor cushions may cause a slip and fall accident." therefore, no corrective or preventive actions are necessary.All complaints are trended on a monthly bases.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
|
Supplemental required for additional information.
|
|
Search Alerts/Recalls
|
|
|