MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD MAC 5500; ELECTROCARDIOGRAPH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/12/2013

Event Type  Injury  

Event Description

This customer reported to the mhra of the uk competent authority that a patient had an unnecessary emergency cardio angiogram with post-operative complications.This was a result of the copy button being accidently used to print the 12 lead ecg report which resulted in a previous patient's report being used to undertake surgical intervention.The complaint reports it appears no secondary/verification of the data took place before commencing surgery.The patient was positively identified from their wristband.

Manufacturer Narrative

This report was incorrectly filed as mdr mfr.Report #2124823-2013-00022.The correct mdr mfr.Report # is 9617277-2014-00003.Patient data not available.The "copy" button on the mac5500 is intended only to print a copy of the ecg last taken, and will include the patient name and id.The mac5500 will print a copy of the previous eg until the eg button, same pat button, or next pat button is hit.Once one of these is selected, the copy is unavailable for printing.Also, after an ecg has been recorded the screen menu changes to prompt for print, same pat, or next pat.Once entered, the patient name and id are visible on the screen and any printed ecg.If patient name and id are missing, selecting ecg will bring up a prompt to enter one or both.It appears that the user did not attempt to enter any demographics for the new printer.The previous patient's demographic information and ecg were maintained on the printed report, and there is no allegation of a patient date mixing on the device.Ge has requested,but not received, the printed report from the complaint.The customer states that no patient information was entered.At the site, further controls and internal procedures were put in place to reduce the likelihood of recurrence, including configuring the cart so that patient id is now required before a recording can be taken.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD; bangalore ; IN
• Manufacturer (Section G): WIPRO GE HEALTHCARE
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 3987623
• MDR Text Key: 17991808
• Report Number: 9617277-2014-00003
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other