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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH
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ARJO HOSPITAL EQUIPMENT AB PARKER BATH Back to Search Results
Model Number AL14110-US
Device Problems Component Falling (1105); Detachment of Device or Device Component (2907); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem Bruise/Contusion (1754)
Event Date 04/03/2014
Event Type  Injury  
Event Description
Initially it was reported by arjohuntleigh rep that after bathing the resident, she was sitting on seat of the tub with her legs out of the tub on the floor, when the tub door fell, brushing her head and landing on her lap and right arm.The caregiver held the door open and got help to remove the resident from the tub.From the info received bruises on right arm occurred as a result of this incident.The patient was taken to x-ray, however, there is no indication that any fracture occurred.Reference mfr report number: 9611530-2014-00030.
 
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Brand Name
PARKER BATH
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 Key3823550
MDR Text Key15819551
Report Number1419652-2014-00121
Device Sequence Number1
Product Code ILM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAL14110-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2014
Distributor Facility Aware Date04/03/2014
Event Location Nursing Home
Date Report to Manufacturer04/29/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight84
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