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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE ONCARE DOLPHIN MATTRESS; MATTRESS, AIR INFLATION, ALTERNATING PRESSURE
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JOERNS HEALTHCARE ONCARE DOLPHIN MATTRESS; MATTRESS, AIR INFLATION, ALTERNATING PRESSURE Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
We have used the dolphin mattress for pts who need pressure redistribution and low air loss therapy.A problem we have identified is that the bed frame and the mattress operate independently.Staff forget to check to ensure the mattress is turned on.We have had several incidents where we have found the pt on a dolphin mattress that is not turned on, this means the pt often found lying directly on a metal bed frame and puts the pt at an actual higher risk for developing a pressure ulcer (the exact problem we are trying to prevent).There are no alarms that cue the staff to the fact that the mattress is not inflated.We feel this is a concerning design flaw, and while we cannot directly link a specific pressure ulcer as a direct cause of the mattress not being inflated, we felt obligated to notify both the mfr and fda of this concern.
 
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Brand Name
ONCARE DOLPHIN MATTRESS
Type of Device
MATTRESS, AIR INFLATION, ALTERNATING PRESSURE
Manufacturer (Section D)
JOERNS HEALTHCARE
MDR Report Key8479586
MDR Text Key140947697
Report NumberMW5085547
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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