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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 GAB1011-01-GB
Device Problem Device Tipped Over
Event Date 09/29/2014
Event Type  Malfunction  
Event Description

Initially it was reported by arjohuntleigh representative that after transferring the patient out of the pool area onto the chair, the staff member maneuvered the chair into the showering area where at this point, the chair tipped or collapsed, and the patient landed on the floor and bruised his left side. On (b)(6) 2014, user facility confirmed that device tipped, not collapsed: "i was not the individual using the hoist when it tipped, it was my colleague (. ). I have trained her this year in the use of the hoist".

 
Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjo hospital equipment ab on behalf of the importer arjohuntleigh, inc ((b)(4)). Additional information will be provided upon completion of the investigation. (b)(4).

 
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Brand NameENTROY
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5,
eslov 2412 1
SW  24121
Manufacturer (Section G)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer Contact
pamela wright
12635 wetmore
ste 308
san antonio , TX 78247
2102787040
MDR Report Key4239863
Report Number9611530-2014-00085
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/01/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberGAB1011-01-GB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2014
Distributor Facility Aware Date10/01/2014
Device Age6 yr
Event Location Hospital
Date Report TO Manufacturer10/30/2014
Date Manufacturer Received10/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/31/2014 Patient Sequence Number: 1
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