MAUDE Adverse Event Report: SIZEWISE SIZEWISE; BIG TURN MATTRESS

Model Number 10686 "BIG TURN MATTRESS"

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Medical device injury, caused by the failure of the bed to maintain air in the mattress.Air hose on a pressure relieving sizewise mattress may have caused a pressure ulcer (suspected deep tissue injury) date defect identified: (b)(6) 2014 at 0900 by rn: patient noticed to be "sinking" into mattress around buttocks area.Motor on bed was sounding louder than usual per the rn, a grinding sound.Sizewise was immediately notified by nursing and rep was out to bedside to troubleshoot.New bed ordered.Serial number or other identifier on the bed: (b)(4) "big turn mattress" name of company: sizewise representative name, title telephone number: (b)(4).Dates of use: (b)(6) 2014.

• Brand Name: SIZEWISE
• Type of Device: BIG TURN MATTRESS
• Manufacturer (Section D): SIZEWISE
• MDR Report Key: 4365035
• MDR Text Key: 5111292
• Report Number: MW5039807
• Device Sequence Number: 1
• Product Code: IKY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2014

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: Other
• Device Model Number: 10686 "BIG TURN MATTRESS"
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 222