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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN (INCL. DIGNITY)
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ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN (INCL. DIGNITY) Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)
Event Date 05/30/2014
Event Type  malfunction  
Event Description
Initially it was reported by arjohuntleigh representative that the patient was ready to be bathed, the seat was swung out of the bath ready for the patient to sit on.The patient approached the seat from the left hand side and as she sat down and started to slide onto the seat, the moulding became detached moving to the right and the moulding and the patient fell to the floor.No injury occurred to the patient or caregiver asa result of this incident.Ref mfr # 9611530-2014-00042.
 
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Brand Name
MALIBU/SOVEREIGN (INCL. DIGNITY)
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer (Section G)
ARJO, INC.
50 north gary ave., suite a
roselle IL 60172 168
Manufacturer Contact
50 north gary ave., suite a
roselle, IL 60172-1684
MDR Report Key3939020
MDR Text Key4571938
Report Number1419652-2014-00170
Device Sequence Number1
Product Code ILM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2014
Distributor Facility Aware Date06/03/2014
Device Age5 YR
Event Location Nursing Home
Date Report to Manufacturer06/27/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
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