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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeDRT
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 7
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUKE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 4
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 7
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 20
HOANA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 3
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 10
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 4
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRESYM, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 8
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
WR MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 15
Device alarm system issue 7
Smoking 5
Device damaged prior to use 2
Monitor failure 2
Premature elective replacement indicator 1
Sensor problems 1
Not audible alarm 1
Component(s), broken 1
Component falling 1
No display or display failure 1
Connection issue 1
No Known Device Problem 1
Alarm system, failure of message-leads off 1
Use of Device Issue 1
Total Device Problems 41

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mindray DS USA, Inc. d.b.a. Mindray North America II Feb-24-2012

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