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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT

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ARJOHUNTLEIGH INC. SPIRIT SELECT Back to Search Results
Model Number CHGSS1
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 08/14/2014
Event Type  malfunction  
Event Description
It has been indicated by the customer that the patient had laid over a night directly on the bed frame.The device has been delivered to the facility on (b)(6) 2014, at 3:52p.M the customer state that the bed was never plugged in by the technician.The service consultant who delivered the spirit select bed with fist step select mattress on it, state that he assisted the hospital's technician in wheeling the bed into the patients room.The bed was plugged in, turned on, patients height/weight parameters has been set and the devices were in working order while the service consultant was present.At that time, the patient was on another bed and has not been transferred to the spirit select bed while the service consultant was present.The device delivery has been signed off by the unit secretary.Patient has been described as having serious medical condition, that needed the therapeutic surface.
 
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.Additional information will be provided upon conclusion of the manufacturer investigation.
 
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Brand Name
SPIRIT SELECT
Manufacturer (Section D)
ARJOHUNTLEIGH INC.
12625 wetmore road, suite 308
san antonio TX 78247
Manufacturer (Section G)
ARJOHUNTLEIGH INC.
12625 wetmore road, suite 308
san antonio TX 78247
Manufacturer Contact
pamela wright
12625 wetmore, ste 308
san antonio, TX 78247
2102787040
MDR Report Key4102047
MDR Text Key4756133
Report Number3010048749-2014-00080
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 User Facility
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 08/15/2014
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? No
Device Operator Health Professional
Device Model NumberCHGSS1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2014
Initial Date FDA Received09/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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