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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EZ WAY, INC. EZ LIFT; LIFT, PATIENT, NON-AC-POWERED
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EZ WAY, INC. EZ LIFT; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 8002
Device Problems Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problems Hemorrhage/Bleeding (1888); Muscle Weakness (1967)
Event Date 06/18/2023
Event Type  Injury  
Event Description
Bariatric ez stand was found to be difficult to maneuver while attempting to pivot a patient from the chair to the bed.During the attempt to transfer patient, her legs weakened causing her arms to fall into the sling of the ez stand.Physical therapist was assisting patient while she was using the ez stand.It was reported that patient "buckled", leaving her suspended by her armpits in the ez stand.Physical therapist was present and assisting appropriately.5 days later, patient became hemodynamically unstable and required intensive care unit (icu) admission for severe bleeding into her axillary area.It is believed that this is a direct result of the ez stand incident.Patient received multiple blood product transfusions, interventional radiology (ir) intervention, and ultimately surgery to stop the very severe bleed.
 
Event Description
Bariatric ez stand was found to be difficult to maneuver while attempting to pivot a patient from the chair to the bed.During the attempt to transfer patient, her legs weakened causing her arms to fall into the sling of the ez stand.Physical therapist was assisting patient while she was using the ez stand.It was reported that patient "buckled", leaving her suspended by her armpits in the ez stand.Physical therapist was present and assisting appropriately.5 days later, patient became hemodynamically unstable and required intensive care unit (icu) admission for severe bleeding into her axillary area.It is believed that this is a direct result of the ez stand incident.Patient received multiple blood product transfusions, interventional radiology (ir) intervention, and ultimately surgery to stop the very severe bleed.
 
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Brand Name
EZ LIFT
Type of Device
LIFT, PATIENT, NON-AC-POWERED
Manufacturer (Section D)
EZ WAY, INC.
807 e. main st
clarinda IA 51632
MDR Report Key17370069
MDR Text Key319484998
Report Number17370069
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2023,07/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2023
Event Location Hospital
Date Report to Manufacturer07/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization; Other;
Patient Age21535 DA
Patient SexFemale
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