MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. MAC 2000; ELECTROCARDIOGRAPH

Model Number 2056333-001

Device Problems Use of Device Problem (1670); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported the user pressed the ecg button and acquired the 10 sec ecg without entering patient data.The same cart was used for another patient without entering the patient data again.Instead of acquiring the ecg of the new patient, the print button was pressed which resulted in printing a copy of the previous patient ecg.Since it was an emergency, it was not realized that the ecg actually belonged to the previous patient and the new patient was medicated based on the ecg report of the previous patient.No negative outcome to the medicated patient was reported.

Manufacturer Narrative

Investigation revealed the previous patient's ecg report was printed and used for the next patient.No patient details were entered for either the first or the second patient who was connected to the mac2000 ecg device, which would have helped to distinguish between the two patient's ecg reports.Since the ecg device was being used in the emergency department the user skipped the step of entering any patient information.The user also failed to notice the different time stamps printed on the two ecg reports.The user ignored the patient data entry prompt message on the mac2000 device and pressed the 'print' key after connecting the second patient.The user missed pressing the 'ecg' key to acquire the ecg for this patient before printing the ecg report.The user was not aware or failed to follow the ecg acquisition workflow, where an ecg has to be acquired before it can be printed.The root cause for the issue reported is 'user error' as the user did not follow the correct workflow for ecg acquisition.The user manual has instruction on the process of ecg acquisition and is specified in the mac2000 operator¿s manual section 5 'entering patient information'.The demonstration of proper workflow was completed and the customer noted the workflow without more incidences.

• Brand Name: MAC 2000
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area; bangalore 56006 7; IN 560067
• Manufacturer (Section G): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area; bangalore 56006 7; IN 560067
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010
• MDR Report Key: 5183662
• MDR Text Key: 29735156
• Report Number: 9617277-2015-00017
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• PMA/PMN Number: K133622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2056333-001
• Device Lot Number: SMT15083077PA
• Other Device ID Number: SMT15083077PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other