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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH ARJO; ROTOPRONE SYSTEM
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ARJOHUNTLEIGH ARJO; ROTOPRONE SYSTEM Back to Search Results
Model Number 209800
Device Problems Device Emits Odor (1425); Loss of Power (1475); Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2017
Event Type  Injury  
Event Description
Patient was on roto-prone bed therapy.Staff caring for patient noted a "rubber smell" followed by a visual spark/orange flash coming from the power "injuction" of the unit.The unit shut down.It was unplugged and removed immediately from service.There was no injury to the patient.The unit was a rental item from the local distributor.The item was removed from service by transferring the patient from the device to a regular intensive care unit bed.Our engineering department removed the device from the treatment location and contacted the local distributor who retrieved the item and replaced it with a new unit.No harm resulted from this incident.Therapy was briefly interrupted with no impact to patient condition.
 
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Brand Name
ARJO
Type of Device
ROTOPRONE SYSTEM
Manufacturer (Section D)
ARJOHUNTLEIGH
2349 w. lake st.
addison IL 60101
MDR Report Key6463365
MDR Text Key72122221
Report NumberMW5068935
Device Sequence Number1
Product Code IKZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/22/2017
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
Device Operator Health Professional
Device Model Number209800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/04/2017
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
Treatment
ABTHERA WOUND VAC SYSTEM; VENTILATOR (B)(6) 2017 - PRESENT
Patient Outcome(s) Required Intervention;
Patient Age21 YR
Patient Weight65
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