MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. EVOLVE; IKY

Model Number PIQEVDPNB3584G

Device Problem Decrease in Pressure (1490)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are aware that this is past the 30 day deadline for reporting.The service unit forwarded the information to the manufacturer regarding the patient outcome with a delay.We have reminded them to review fda reporting guidelines in order to prevent this from happening again.Additional information will be provided upon conclusion of the manufacturer investigation.

Event Description

Arjohuntleigh has been informed that a female patient, who was using an evolve mattress, was reported in bad condition, developing stage 4 pressure ulcer.The change of position was impossible, therefore the facility provided a vac therapy as a therapeutic technique.After few days, the facility staff checked the mattress condition and found out that the mattress was bottoming out.

Manufacturer Narrative

(b)(4).Arjohuntleigh has performed an in depth investigation into the issue and concluded the following: the evolve mattress involved in this incident has been identified with serial number: (b)(4) and model number: piqevdpnb3584g.The unit was manufactured on 2012-10-12 and is a generation 1 of the piq design.The mattress is manufactured by arjohuntleigh (b)(4) in accordance to the approved work instruction.The piq evolve system is pressure tested during an in-process test phase.If it passes the set criteria at this gate then the system is released to the next gate for finish assembly.With the complaint at hand and we have been informed that a "corpulent" patient (the exact weigh has not been provided) was using a mattress, with no turning protocol applied.After a few days, during their skin care procedure it was noticed that mattress was perceived to be bottoming out and the patient developed a stage 4 pressure ulcer.The exact patient preexisting condition remain unknown, however the overall condition was described as "bad".Additionally, it is worth to be noted that the caregiver did not indicate a mattress issue as a contributory factor to the patient outcome.During the investigation, it has been shown that the unique properties of the evolve mattress design include a greater immersion not typical of other foam mattresses, which means it may show an indentation at the body section of the mattress after use.This product characteristic may be associated by the users as a malfunctioning mattress and "bottoming out".In fact the mattress has a foam bottom layer and even if there is no air in any of the pods - which was not the case here- the mattress does not "bottom out" onto the bed because there is still that foam layer providing support.Therefore actual "bottoming out" is technically not possible with this mattress.The user could view that there is a very high immersion in the mattress and consider it to be excessive without realizing that these mattresses were designed for such immersion.It is worth to be noted that user manual (#413657-ah rev.C) provided with each device includes information how to perform a proper skin care while patient is on the mattresses.It also informs the user about necessity to monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients.In addition there has been a field action that included the update of the ifu to include information that underlines that this is a mattress that provides a high level of immersion, to avoid misunderstandings.It appears to have been successful in that the customer did not point to the mattress being defective, however they still not seem to have grasped the correct description of "bottoming out".This may be more related to the use of the term internal to the customer than to the ifu description.The mattress involved in this incident has been tested by arjohuntleigh technician, who checked the condition of internal components and found a hole in the middle pods causing them to not function (expand) while the applied pressure was relieve.This failure is likely to occur as a result of fatigue of the parts due to the load or forces applied inter alia by transfer inside customer facility, storage there next to sharp objects, needle sticks or customer weight.In summary, with all information gathered it was concluded that pods of the mattresses were damaged however based on the performed risk evaluation and pressure mapping it appears to be unlikely that such failure on its own was a contributory factor to the 4 stage pressure ulcer occurrence.Upon the performed investigation, it was concluded that the patient outcome was an effect of combination of following factors: the pre-existing health state, lack of position change and constant laying position and a failure of the mattresses' pods.Arjohuntleigh device has played a role in the event, as it was used for the patient treatment.The injuries sustained were classified as a serious injuries, thus the event was decided to be reportable to competent authorities as such type.Given the circumstances and the fact, that there is no trend observed for similar adverse events, arjohuntleigh does not propose any other action at this time.

• Brand Name: EVOLVE
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5659252
• MDR Text Key: 45302030
• Report Number: 3007420694-2016-00090
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/09/2016,01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PIQEVDPNB3584G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2016
• Distributor Facility Aware Date: 01/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2016
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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): Required Intervention