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

Device Problems Air Leak (1008); Structural Problem (2506)

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

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration#1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration #3009988881.From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.The customer called that the mattress with serial no (b)(4) experienced indentation in the middle.A service consultant, who previously talked with the customer regarding the reportable incident, and who received notification from the service team that the facility had called regarding indented mattress, mistakenly assumed that another injury had occurred, whereas, in fact, there was only one - reported before under medwatch number 3007420694-2016-00115 and with our reference (b)(4).A patient with deep tissue injury was moved the same day from one evolve mattress, involved in the initial event, serial no (b)(4) (registered under complaint (b)(4)) to another evolve mattress serial no (b)(4) (investigated here).Based on the initial allegation that 'another patient injury' occurred while using the evolve mattress in (b)(6) new complaint has been registered in trackwise complaint handling system under (b)(4).Initially, it was decided that the complaint is to be reportable based on the allegation of the patient outcome that was initially alleged by a member of customer staff, however further investigation and received information led us to the conclusion that the second allegation was related to the mattress having indentation in the middle and not related to the patient developing injury while being on this mattress.The mattress with serial number (b)(4) was returned for evaluation, during which minor leaks from the tubing was found.Despite this minor manufacturing defect arjohuntleigh has confirmed that the evolve mattress met the manufacturer requirements regarding allowable pressure value, even, with the worst case scenario, where sat valves and tubing, which allow air flow to the pods, were removed from the mattress.The mattress passed, also, indentation test as per ifu.Please note that, the mattress indentation shall be measured on a flat surface.The enterprise bed, on which mattress was placed has a curvature of plastic deck.If mattress is not tested on a flat surface, as indicated per user manual, it will fail due to a bend in the bed surface.The 3 inch topper foam prevents immediate harm to the patient allowing the facility to take action if they are follow the standard guidelines set forth in the "(b)(4)" guidelines and instruction incorporated in user manual.All devices in the field including all the 60 gram units function as designed and the risk requirements were met per our design failure modes and effects analysis.In summary, although initially the complaint has been determined to be reportable based on the allegation of patient injury, after conducting a scrutiny investigation, it has been deemed that this complaint is not a reportable event.The mattress was being used with a patient and in that way was pointed to be involved in the complaint, the mattress failed to meet its specification since a minor leak in tubing has been found, however it could be shown that regardless of the leak, mattress still performed as intended, because of the foam that prevents immediate harm to the patient allowing the facility to take an appropriate actions according to user manual e.G.413657-ah rev.C and/or "(b)(4)" guidelines.There was no injury to the patient in relation to this mattress.Patient injury was related to the previous issue related to mattress with serial no (b)(4).The results of the investigation performed enable us to determine that failure of leaks in tubing does not compromise patient safety and therefore will no longer be seen as reportable type of event.

Event Description

Initially, it was reported by the service consultant that 'another patient injury' occurred while using the evolve mattress in (b)(6).Based on this allegation, the complaint has been registered in trackwise complaint handling system.Please note, that the same day the customer had alleged that a patient, age (b)(6) year old, male, weight (b)(6) , had a deep tissue injury to left lower sacral area while using evolve mattress.This allegation had been registered in trackwise complaint handling system under different number.The two allegations led to a conclusion that two mattresses were involved in two different incidents reported by the same customer.Upon further investigation and after collecting an additional information it turned out that, in fact, the customer reported one incident only with the patient, age (b)(6) year old, male, weight (b)(6) , which has been already registered in trackwise complaint handling system.A service consultant received notification from the service team that the facility had called regarding indented mattress.A service consultant, who previously talked with the customer regarding the reportable incident, mistakenly assumed that another injury had occurred, whereas, in fact, there was only one.A patient with deep tissue injury was moved the same day from one evolve mattress, serial no (b)(4) to another evolve mattress serial no (b)(4) (which is investigated here).The customer called that the mattress with serial no (b)(4) experienced indentation in the middle.Patient injury was related to the previous issue related to mattress with serial no (b)(4).Initially, it was decided that the complaint is to be reportable based on the allegation of the patient outcome, however further investigation and received information led us to the conclusion that the second allegation was related to the mattress having indentation in the middle and not related to the patient developing injury while being on this mattress.

• Brand Name: EVOLVE
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6035908
• MDR Text Key: 57683342
• Report Number: 3007420694-2016-00209
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/18/2016,06/07/2016

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Distributor Facility Aware Date: 06/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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