BURDICK T600 TREADMILL 92401 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-14 for BURDICK T600 TREADMILL 92401 NA manufactured by Cardiac Science Corporation.

Event Text Entries

[1768829] Customer stated they had just started the treadmill at minimum speed. The patient stepped on the treadmill and a short time later the treadmill sped up to maximum speed. At some point the patient fell off the treadmill. Patient reported some minor soreness. The doctors checked her over several times and said she was okay. Patient refused any further treatment.
Patient Sequence No: 1, Text Type: D, B5


[8689539] Cardiac science field service engineer was dispatched to the site. He replaced a treadmill control board and interface cable. The system was tested twice in a bruce protocol with no problems found. A functional test was also completed. The original parts are being returned to the manufacturer. When further information becomes available a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3014398-2010-00029
MDR Report Key1873609
Report Source05,06
Date Received2010-09-14
Date of Report2010-08-16
Date of Event2010-08-16
Date Mfgr Received2010-08-19
Device Manufacturer Date2004-05-01
Date Added to Maude2011-05-03
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 ContactBEV MAGRANE
Manufacturer Street3303 MONTE VILLA PKWY.
Manufacturer CityBOTHELL WA 98028
Manufacturer CountryUS
Manufacturer Postal98028
Manufacturer Phone4254022365
Manufacturer G1CARDIAC SCIENCE CORPORATION
Manufacturer Street500 BURDICK PARKWAY
Manufacturer CityDEERFIELD WI 53531
Manufacturer CountryUS
Manufacturer Postal Code53531
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBURDICK T600 TREADMILL
Generic NameCARDIAC STRESS TESTING TREADMILL
Product CodeIOL
Date Received2010-09-14
Model Number92401
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARDIAC SCIENCE CORPORATION
Manufacturer Address3303 MONTE VILLA PKWY. BOTHELL WA 98028 US 98028


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.