MAUDE Adverse Event Report: HILL-ROM, INC HILL ROM TEMPUR PEDIC COMFORT PAD; COVER, MATTRESS (MEDICAL PURPOSES)

Model Number	P3612TP
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Elastic band no longer functional.Causes overlay to move on mattress, even hang over the edges of the normal mattress.Training upon receipt of the affinity 4 beds: staff instructed to pull overlay over the bed frame.Elastic quickly worn out in less than 1 year, overlays replaced by hill-rom with new instruction to pull the overlay over the mattress, not the bedframe occurred.Gathering of tempurpedic material, causing a lateral lump across the lumbar area.Many patient complaints about discomfort with the overlays.Visible discoloration outlines with irregular boarders on the overlay cover, despite following manufacturing cleaning guidelines.Manufacturer response for hill rom mattress overlay, hill rom mattress overlay (per site reporter).Hill-rom came out to assess.No explanation of problem and no offer to repair/replace.

• Brand Name: HILL ROM TEMPUR PEDIC COMFORT PAD
• Common Device Name: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6739743
• Report Number: 6739743
• Device Sequence Number: 1432869
• Product Code: FMW
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 07/19/2017
• Report Date (Section F): 07/19/2017

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
• Operator of Device: No Information
• Device Model Number: P3612TP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/19/2017