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U.S. Department of Health and Human Services

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

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WIPRO GE HEALTHCARE PRIVATE LTD. MAC 2000 ELECTROCARDIOGRAPH Back to Search Results
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.

 
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Brand NameMAC 2000
Type of DeviceELECTROCARDIOGRAPH
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 Key5183662
MDR Text Key29735156
Report Number9617277-2015-00017
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
PMA/PMN NumberK133622
Number of Events Reported1
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 Received10/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2056333-001
Device LOT NumberSMT15083077PA
OTHER Device ID NumberSMT15083077PA
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1970
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/28/2015 Patient Sequence Number: 1
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