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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

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ARJOHUNTLEIGH INC. ROTOPRONE Back to Search Results
Model Number 209500
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Fall (1848)
Event Date 02/02/2014
Event Type  malfunction  
Event Description
Per the fda letter regarding report nol mw5034337, received by arjohuntleigh on (b)(6) 2014, the customer reported the rotoprone bed was not working properly.As the pt was supine, rotation therapy was started.Limits were set at 45 degrees for left and right rotation.Bed rotated pt greater than 60 degrees and pt almost fell out of the bed.Nurses had to hold pt in the bed while the cpr button at the computer site was pushed to bring the pt back down to 0 degrees supine.Also, bed would not allow proper functioning during normal therapy settings.There was no injury reported due to this event.Arjohuntleigh is reporting this event with an abundance of caution as if this type of event were to recur, it may cause or contribute to death, serious injury or medical intervention to prevent harm.
 
Manufacturer Narrative
This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.This report is being filed late due to lack of the arjohuntleigh complaints dept.The complaint process regarding field employees is being reviewed and will be addressed in a supplemental report.Add'l info will be provided upon conclusion of the manufacturer investigation.
 
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Brand Name
ROTOPRONE
Manufacturer (Section D)
ARJOHUNTLEIGH INC.
12625 wetmore rd
ste 308
san antonio TX 78247
Manufacturer (Section G)
ARJOHUNTLEIGH INC.
12625 wetmore rd
ste 308
san antonio TX 78247
Manufacturer Contact
pamela wright
12625 wetmore
ste 308
san antonio, TX 78247
2102787040
MDR Report Key3847699
MDR Text Key18868826
Report Number3010048749-2014-00012
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2014
Initial Date FDA Received03/18/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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