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

Model Number P3612TP

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Event 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
• Type of Device: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6739743
• MDR Text Key: 80926109
• Report Number: 6739743
• Device Sequence Number: 1
• Product Code: FMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3612TP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1