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

Model Number PIQ-EVDPNB-3584

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer investigation.

Event Description

Arjohuntleigh has been informed about the incident that took place 2 weeks earlier, yet no exact date was provided.According to the information given it appears that a patient, who was using evolve mattresses, developed a deep tissue injury on the coccyx area.The complaint was decided to be reportable based on the patient outcome.

Manufacturer Narrative

(b)(4).The results of the investigation performed enable us to determine that failure of pods or leaks in tubing does not compromise patient safety and therefore will no longer be seen as reportable type of event.On (b)(6) 2016 arjohuntleigh was informed about the incident that took place 2 weeks earlier, yet no exact date was provided.According to the information given, it appears that a patient, who was using evolve mattress, developed a deep tissue injury on the coccyx area.It was claimed that the mattress bottomed out.According to the nurse the patient was sedated, on a ventilator and turning protocol was performed.The evolve mattress involved in this incident has been identified with serial number: (b)(4) and model number: piq-evdpnb-3584.The device involved in this incident is a second generation of the piq design with 70 gram pods and tubing encompassed in the foam base.The involved in the event mattress has not been tested by the manufacturer since it could not have been located by the facility.The customer, however, returned back four mattresses, which have been inspected.It was found that one mattress had a check valve leaking, two had helix pod with holes and third had a leaking harness assembly.Performed tests as indicated in the reports (b)(4) proven that even with minor defects of sat system, such as cracks in pods or leaks in tubing, the device performs as intended and the interface pressure meets the design requirements.The 3 inch topper foam is preventing immediate harm to the patient allowing the facility to take action if they are follow the standard guidelines set forth in the "npuap" (national pressure ulcer advisory panel) 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, arjohuntleigh device has played a role in the event, as it was used for the patient treatment and therefore contributed to the outcome of the event.The customer could not point out the mattress that was part of the indicated event, however four mattresses were taken from the facility for testing and the performed test has proven that the mattresses that were returned for investigation met the required pressure index and perform as intended even when there might be a defect, because of the foam layer that prevents immediate harm to the patient.The risk of patient serious injury has been determined as low.As the mattress involved in the incident could not be found by the facility, it has been not possible to clearly state whether the device was found to have been up to the specification when the event took place as no evaluation of the involved mattress was performed at the customer location directly after the event since the customer could not point out the mattress that was involved in the event, however it is possible to indicate several factors that might be contributing to the patients outcome: pre-existing health state, exceeded patient weight (the system is design for patient weighing up to 500 lb(227 kg)), improper patient placement on the mattress, incompatible bed frame use or monitoring not properly adjusted to the patient's condition.Please note, that we report this event due to the patient outcome while using our device not according to instructions and not due to the device failure.Should we obtain any information that would change the outcome of our complaint investigation, an update will be sent to authority.

• 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: 5719761
• MDR Text Key: 47211169
• Report Number: 3007420694-2016-00110
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/11/2016,05/25/2016

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: Health Professional
• Device Model Number: PIQ-EVDPNB-3584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2016
• Distributor Facility Aware Date: 05/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2016
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• 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