MAUDE Adverse Event Report: AROJOHUNTLEIGH PRESSURE IQ EVOLVE 35X80; MATTRESS

Model Number PIQ-EV-DPNB-358

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Skin Discoloration (2074); Tissue Damage (2104); Discomfort (2330)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

The mattress was being evaluated with the vendor on site.During the review of this mattress, it was found to not be performing at the optimum level and was verified to be "bottoming out" with pressure to the seat area.The patient complained of discomfort when evaluated by the wound care nurse, the patient was noted to have a deep tissue injury to the sacrum.Wound care evaluation on (b)(6) 2017 "pt seen at request from nursing for dark area of skin at the buttocks.Pt c/o discomfort at the area.Tender to touch.Lying on a pillow at the buttocks area with pain relief.Discussed with staff nurse for activation of order set for deep tissue injury to the discoloration on the right buttocks.Will obtain low air loss mattress.Pt has been placed on skin iq.Nursing to continue the skin iq also.Will initiate mist therapy to the area.

• Brand Name: PRESSURE IQ EVOLVE 35X80
• Type of Device: MATTRESS
• Manufacturer (Section D): AROJOHUNTLEIGH; dallas
• MDR Report Key: 6328883
• MDR Text Key: 67506410
• Report Number: MW5067867
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIQ-EV-DPNB-358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 57