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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE AB RISEATLAS 450MQ; CEILING LIFT
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HANDICARE AB RISEATLAS 450MQ; CEILING LIFT Back to Search Results
Model Number 50100041
Device Problems Component Falling (1105); Unintended Movement (3026); Device Fell (4014)
Patient Problems Abrasion (1689); Bruise/Contusion (1754)
Event Date 06/01/2018
Event Type  malfunction  
Event Description
Riseatlas motor fell on the nurse's arm.Visible abrasion and bruising on nurse left forearm and paramaedics was called for diagnosis.No broken bones.
 
Manufacturer Narrative
Results from internal investigation indicate that the event was most likely caused by user error.It was disclosed to handicare during investigation that the customer had modified the turntable system prior to the event.Internal investigation concludes that the event was most likely caused by hazards from using a modified device.Manufacturer sees no reason for further action at this time but will continue to monitor this type of event.
 
Event Description
Riseatlas motor fell on the nurse's arm.Visible abrasion and bruising on nurse left forearm and paramaedics was called for diagnosis.No broken bones.
 
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Brand Name
RISEATLAS 450MQ
Type of Device
CEILING LIFT
Manufacturer (Section D)
HANDICARE AB
torshamnsgatan 35
kista, 16440
SW  16440
MDR Report Key7607051
MDR Text Key111896194
Report Number3009481053-2018-00026
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Type of Report Initial,Followup
Report Date 06/15/2018,11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50100041
Device Catalogue Number514110085
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/15/2018
Supplement Dates Manufacturer Received06/04/2018
Supplement Dates FDA Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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