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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB FREEDOM BATH
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ARJO HOSPITAL EQUIPMENT AB FREEDOM BATH Back to Search Results
Model Number AF24104US00
Device Problem Leak/Splash (1354)
Patient Problems Fall (1848); Pain (1994)
Event Date 05/21/2014
Event Type  malfunction  
Event Description
Initially, it was reported by arjohuntleigh representative that while giving whirlpool bath caregiver heard the seal start to deflate.She stated that water started rushing out of bottom of tub.She stated that at this point she slipped and fell.She landed on back.As a result of this incident caregiver sustained pain in shoulder, right hamstring and lower back.No treatment applied.The caregiver refused to go to occupational health treatment.Mfr report #: 9611530-2014-00039.
 
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Brand Name
FREEDOM 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 Key3964794
MDR Text Key4626138
Report Number1419652-2014-00163
Device Sequence Number1
Product Code ILM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAF24104US00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2014
Distributor Facility Aware Date05/21/2014
Device Age2 NA
Event Location Nursing Home
Date Report to Manufacturer06/20/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
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