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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T.H.E. MEDICAL BARRIE TOLLOS
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T.H.E. MEDICAL BARRIE TOLLOS Back to Search Results
Model Number CIRRUS 600LBS
Device Problems Detachment Of Device Component (1104); Material Separation (1562)
Patient Problem Fall (1848)
Event Date 05/21/2015
Event Type  Injury  
Event Description
Team was preparing to get the patient out of bed using the ceiling lift.The sling had been appropriately positioned under the patient.While the ceiling lift was being lowered into position so that the sling straps could be attached, the lift mechanism literally fell apart - the metal nuts, rings and bolts fell out detaching the lift bar.All components fell down upon the bed striking the patient in the chest.The estimated fall distance was about 18".The cna standing at patient's right side and broke the fall of the components with cna's hands, but that still made impact with the patient's lower chest/upper abdomen (approx 3"-4" above g-tube site).The patient reported they were "fine".Patient's chest and abdomen were examined immediately by the rn.No redness, tenderness, bruising.Chest and abdomen totally mark and injury free.Md examined the patient upon arrival.No injury and no further work-up ordered.
 
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Brand Name
TOLLOS
Type of Device
TOLLOS
Manufacturer (Section D)
T.H.E. MEDICAL BARRIE
ontario CA
MDR Report Key4867547
MDR Text Key5866070
Report NumberMW5043213
Device Sequence Number1
Product Code FNG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCIRRUS 600LBS
Other Device ID NumberCSA NO. 601.1/UL NO 2601-1
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
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