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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYE'S, INC.; BED, AC-POWERED ADJUSTABLE HOSPITAL, RENTAL
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RAYE'S, INC.; BED, AC-POWERED ADJUSTABLE HOSPITAL, RENTAL Back to Search Results
Catalog Number EVO
Device Problem Malposition of Device (2616)
Patient Problem Respiratory Distress (2045)
Event Date 04/17/2018
Event Type  malfunction  
Event Description
Patient is in a sizewise bed because of skin break down.Bed is labeled "evoxxxxx".Patient was incontinent of stool and head of bed lowered to clean patient.At end of cleaning patient, head of bed would not go back up.Connections checked on controller and all working.Head of bed would go down, just not up.Patient experienced respiratory distress and patient transferred into new bed with sling and lift.Bed removed from service.Variance placed and sizewise called.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Patient is in a sizewise bed because of skin break down.Bed is labeled "evoxxxxx".Patient was incontinent of stool and head of bed lowered to clean patient.At end of cleaning patient, head of bed would not go back up.Connections checked on controller and all working.Head of bed would go down, just not up.Patient experienced respiratory distress and patient transferred into new bed with sling and lift.Bed removed from service.Variance placed and sizewise called.
 
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Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL, RENTAL
Manufacturer (Section D)
RAYE'S, INC.
204 w. 2nd st.
ellis KS 67637
MDR Report Key7486472
MDR Text Key107352981
Report Number7486472
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue NumberEVO
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2018
Event Location Hospital
Date Report to Manufacturer04/25/2018
Patient Sequence Number1
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