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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. THERAPULSE ATP
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ARJOHUNTLEIGH, INC. THERAPULSE ATP Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2014
Event Type  malfunction  
Event Description
The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the bed had a burning smell.The nurses noted that there was smoke coming from the bed.A fire retardant was sprayed on the bed's under bed inverter (ubi).There was no injury associated with this event.The patient was moved to a new bed and arjohuntleigh's service representative was called to pick up the bed that was smoking.
 
Manufacturer Narrative
This report is being filed by the manufacturer arjohunteligh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of november 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
THERAPULSE ATP
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 Key3983334
MDR Text Key4820160
Report Number3010048749-2014-00077
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/18/2014
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2014
Initial Date FDA Received07/02/2014
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 Unknown
Patient Sequence Number1
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