MIST THERAPY SYSTEM CP-80004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-15 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..

Event Text Entries

[15184052] Nurse called to report operational issue with mist therapy system, and that she had touched the end of the transducer to see if the horn was broken. She stated the transducer was hot, burned through her glove, and burned her finger, resulting in a blister. Several attempts to contact the reporter for add'l info about the reported event have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5


[15653272] Mfr's eval of system involved in reported event revealed system operating within temperature specifications. An attempt was made to duplicate the report of the horn being hot enough to burn through a glove, however, the mfr was unable to do so, as the horn tip does not reach a temperature sufficient to burn through a latex glove when the ultrasound is off.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004580659-2008-00002
MDR Report Key1031761
Report Source05
Date Received2008-04-15
Date of Report2008-04-15
Date of Event2008-03-28
Date Mfgr Received2008-03-28
Device Manufacturer Date2007-03-01
Date Added to Maude2009-10-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKATHY SIMPSON, CONSULTANT
Manufacturer Street10250 VALLEY VIEW ROAD SUITE 137
Manufacturer CityEDEN PRAIRIE MN 55344
Manufacturer CountryUS
Manufacturer Postal55344
Manufacturer Phone9522248700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIST THERAPY SYSTEM
Generic NameNONE
Product CodeNRB
Date Received2008-04-15
Returned To Mfg2008-04-08
Model NumberCP-80004
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCELLERATION, INC.
Manufacturer AddressEDEN PRAIRIE MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-04-15

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