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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. COROMETRICS 174 MONITOR
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WIPRO GE HEALTHCARE PRIVATE LTD. COROMETRICS 174 MONITOR Back to Search Results
Model Number CORO 174
Device Problem Defective Device (2588)
Patient Problem Not Applicable (3189)
Event Date 04/03/2015
Event Type  malfunction  
Event Description
It was reported that the corometrics 174 fetal monitor was not configured properly during the mfg process for the fetal heart rate (fhr) lower alarm limit.The fhr was configured to 50 beats per minute (bpm) instead of 120 bpm on the device that was configured at the ge border operations factory.The issue was discovered during installation prior to pt use.
 
Manufacturer Narrative
Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.
 
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Brand Name
COROMETRICS 174 MONITOR
Manufacturer (Section D)
WIPRO GE HEALTHCARE PRIVATE LTD.
bangalore
IN 
Manufacturer (Section G)
WIPRO GE HEALTHCARE PRIVE LTD
bangalore
IN  
Manufacturer Contact
james giles
3000 n grandview blvd
waukesha, WI 53188
2625482089
MDR Report Key4751434
MDR Text Key5773906
Report Number9617277-2015-00011
Device Sequence Number1
Product Code HGM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCORO 174
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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