MAUDE Adverse Event Report: ARJO HUNTLEIGH POLSKA SP. Z O.O. EVOLVE

Device Problem Insufficient Information (3190)

Patient Problems Ulcer (2274); Injury (2348)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has been informed that deep tissue injury was found while a patient was using an evolve mattress.The nurse reported that the patient had bottomed out onto the hard surface.The patient was moved to a different evolve mattress.

Manufacturer Narrative

(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.On (b)(6) 2016 arjohuntleigh was informed that a deep tissue injury to left lower sacral area was found while a patient, (b)(6), male, (b)(6), was using evolve mattress.According to the nurse, the plastic of pods could have been felt through the foam and the patient had bottomed out onto the hard plastic surface.It was claimed that the mattress failed the indentation test of 2.5" as per user manual.The patient was moved to a different evolve mattress.The mattress was purchased in (b)(6) 2015 an utilized on enterprise frame.According to the nurse, the patients that use the evolves are those with braden scale of 13-18 (low to moderate risk).There was also information provided that the patient actually did not develop a pressure ulcer, it was a skin redness which disappeared after few days, this information, however, has not been confirmed with a certainty.The evolve mattress involved in this incident has been identified with serial number: (b)(4).The patient later the same day was moved to a different evolve mattress with serial number (b)(4).The device is a second generation of the piq design with 70 gram pods and tubing encompassed in the foam base.The mattress involved in the initial event 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 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.We were able to list several factors that could contribute to patient outcome as indicated by one of the observation that took place during a site visit to the customer: pre-existing health state, improper patient positioning on the bed or monitoring not properly adjusted to the patient's condition.In summary, arjohuntleigh mattress 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 mattress in this regards failed to meet its specification, however there is no indication or evidence that an actual injury has occurred in relation to the use of the evolve mattresses, and the risk of patient serious injury has been determined as low.Nevertheless, since the allegation was that the patient was found with a deep tissue injury while on the evolve mattress, despite the fact that the actual injury could not be confirmed, the complaint was decided to be reportable to competent authorities 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: EVOLVE
• Manufacturer (Section D): ARJO HUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP.Z O.O.; ul. ks. 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: 5747559
• MDR Text Key: 48096871
• Report Number: 3007420694-2016-00115
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 10/14/2016,05/26/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2016
• Distributor Facility Aware Date: 05/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• 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
• Patient Age: 92 YR
• Patient Weight: 41