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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

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ARJO HOSPITAL EQUIPMENT AB ENTROY Back to Search Results
Model Number GAB1000-01-EU
Device Problems Use of Device Problem; Device Tipped Over; Detachment of Device or device Component
Event Date 03/13/2014
Event Type  Injury  
Event Description

Initially it was reported by arjohuntleigh representative that during docking from entroy arm to the chair the handle has been pulled out before docking was completed and the seat was not in the right position. When the caretaker started to move the patient, the seat tipped and the patient fell to the floor. From the received information injury to the patient occurred: swelling forehead, bruise on knee and redness on inner elbow. Reference mfr report 9611530-2014-00027.

 
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Brand NameENTROY
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW  24121
MDR Report Key3832478
Report Number1419652-2014-00107
Device Sequence Number1
Product CodeFNG
Report Source Distributor
Source Type Unknown
Reporter Occupation
Type of Report Initial
Report Date 03/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberGAB1000-01-EU
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2014
Distributor Facility Aware Date03/18/2014
Event Location Other
Date Report TO Manufacturer04/17/2014
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/17/2014 Patient Sequence Number: 1
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