MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD COROMETRICS 174 MONITOR; PERINATAL MONITORING SYSTEM

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 172 fetal monitor was not configured properly during the manufacturing 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.No report of serious injury.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.Block a: patient data was not provided by the hospital.

• Brand Name: COROMETRICS 174 MONITOR
• Type of Device: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD; bangalore ; IN
• Manufacturer (Section G): WIPRO GE HEALTHCARE PRIVATE LTD; bangalore ; IN
• Manufacturer Contact: james giles ; 3000 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 4751446
• MDR Text Key: 16540579
• Report Number: 9617277-2015-00009
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993751
• Number of Events Reported: 1
• 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 Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORO 174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1