MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD COROMETRICS 172 MONITOR; PERINATAL MONITORING SYSTEM

Model Number CORO 172

Device Problem Defective Device (2588)

Patient Problem Not Applicable (3189)

Event Date 03/18/2015

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.There was no patient involvement since the issue was discovered by ge healthcare personnel during installation of the monitor prior to patient use.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.

• Brand Name: COROMETRICS 172 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 ; 2625482089
• MDR Report Key: 4706466
• MDR Text Key: 5668337
• Report Number: 9617277-2015-00003
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CORO 172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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