|
Model Number PIQ-EV-DPNB3584-N |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
Discomfort (2330)
|
Event Type
malfunction
|
Event Description
|
On (b)(6) 2014, the following was reported by the arjohuntleigh account executive (ae): in (b)(6) 2013, 19 evolve mattresses were purchased by the facility for a new intensive care unit that would be opened on (b)(6) 2013.Presently all 19 mattresses are visibly depressed in the center.The patients that were on the mattresses were complaining that the depression in the mattresses made changing positions difficult as well as making the mattresses uncomfortable.When the ae inspected the mattresses, the helix pods were visibly compressed and low.If this malfunction were to recur, it may cause or contribute to serious injury or medical intervention to prevent harm.Therefore this malfunction is reportable.This complaint is number 14 of 19 complaints regarding the mattresses at this facility.
|
|
Manufacturer Narrative
|
This report is being filed by the manufacturer arjohuntleigh, inc.((b)(4)).Previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.((b)(4)).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.And (b)(4).Additional information will be provided upon conclusion of the manufacturer investigation.
|
|
Search Alerts/Recalls
|
|
|