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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. PRO + FLAT DECK MATTRESS; BED, FLOTATION THERAPY, POWERED
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HILL-ROM, INC. PRO + FLAT DECK MATTRESS; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P7924A03
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2024
Event Type  malfunction  
Event Description
The hill-rom pro+ mattresses, model #: p7924a03 are showing issues with the covers and foam assembly failing.The covers are delaminating.This has been brought to the manufactures attention i am awaiting further details.Our current fleet of 124 mattresses are all showing the same issue with the cover.All at various states of delamination.From what i can tell our covers are showing the same problems as this fda recall.Recall number: z-1482-2023, recall event id: (b)(4).None of our serial¿s numbers are listed on the recall though.The foam assemblies are failing causing the patients to bottom out and no longer receive proper care.The foam assembly fails and you can see a visible dip in the center and head section of the mattress.The foam assembly is not a repairable item and the entire mattresses assembly has to replace under warranty.To date our hospital replaced 18 units.With another 12 units called in for warranty replacement.I can provide more pictures if needed to show what i call bottoming out.
 
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Brand Name
PRO + FLAT DECK MATTRESS
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM, INC.
MDR Report Key19208365
MDR Text Key341506480
Report NumberMW5154401
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/25/2024
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
Device Operator Health Professional
Device Model NumberP7924A03
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2024
Patient Sequence Number1
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