MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS LATERAL ROTATION AND TRUE LOW AIR LOSS 9153650078; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number TURN Q PLUS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

It was reported by a caller from an unknown facility that the unknown turn q plus mattress is leaking.The end user has allegedly sustained bed sores due to the mattress not working properly.Caller stated that the user resides in a nursing facility and the unit has been broken for months.Called advised that he works for a health center and for the end users doctor.Caller could not provide any further information.

• Brand Name: LATERAL ROTATION AND TRUE LOW AIR LOSS 9153650078
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4597188
• MDR Text Key: 5470534
• Report Number: 1031452-2015-11445
• 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: User Facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 03/09/2015

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: Lay User/Patient
• Device Model Number: TURN Q PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 03/13/2015
• 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