MAUDE Adverse Event Report: HILL-ROM, INC. HILL-ROM PRO+ SURFACE; BED, FLOTATION THERAPY, POWERED

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

Hillrom pro surface mattresses tearing and leaking fluid.Mattresses located on several different units.Removed from service.Three have intrusion and need a totally new replacement surface.One surface that needs new cover, but i did not identify any fluid intrusion.

• Brand Name: HILL-ROM PRO+ SURFACE
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 18977531
• MDR Text Key: 338576481
• Report Number: 18977531
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1