MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. MAC 3500; ELECTROCARDIOGRAPH

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Data Problem (3197)

Patient Problem No Code Available (3191)

Event Date 02/25/2015

Event Type  Injury  

Event Description

The customer reported a user pressed the "copy" button on the device instead of the "acquire" button while connected to a patient.The patient demographic information was not entered into the device so when the ecg printed, it could not be confirmed if the abnormal ecg that printed was actually for the patient it was connected to.The patient received medication for acute myocardial infarction and was admitted for close observation, serial ecg's and blood tests to the coronary care unit (ccu) as per the hospital's standard practice prior to the error being noted.The error was noted by a cardiologist in the ccu after treatment of the patient.The patient had a slightly extended stay in the ccu because of the treatment but the length of stay in the hospital was not extended as a result.

Manufacturer Narrative

Patient information unavailable.This record represents patient 2 of 2.Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation is complete.

Manufacturer Narrative

Investigation revealed the mac 3500 ecg device is behaving as intended.The user pressed the "print" soft key instead of "ecg" key.The "print" soft key is expected to print the last acquired ecg.For any new patient, the user is expected to acquire the new ecg using "ecg" button on the device.The mac3500 operators manual ge part no.2046275-018 (section 4, page 51) also contains a caution as below; caution: inaccurate patient data [?] patient data may be retained from a previous patient.Check the patient info screen for each new patient.Data assigned to the wrong patient causes erroneous patient data that can affect diagnosis and treatment of the patient(s).Make sure that you enter patient data for the correct patient.The field engineer (fe) instructed the customer which button to press to obtain an ecg, and the need to enter the patients id number before performing an ecg, which would remove the previous ecg from memory.The fe has changed the settings on the machine such that the patient id is made mandatory in the cart setup.

• Brand Name: MAC 3500
• 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, 5600 67; IN 560067
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4628452
• MDR Text Key: 16859399
• Report Number: 9617277-2015-00002
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K110266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other