• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WIPRO GE HEALTHCARE PRIVATE LTD. MAC 3500 ELECTROCARDIOGRAPH Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Myocardial Infarction (1969)
Event Date 02/25/2015
Event Type  Injury  
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.

 
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 1 of 2. Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation is complete.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAC 3500
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, 5600 67
IN 560067
Manufacturer Contact
deb lahr
540 w. northwest hwy
barrington, IL 60010
8472774472
MDR Report Key4628512
MDR Text Key13445812
Report Number9617277-2015-00001
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberK110266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
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 Received03/24/2015
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 Received05/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/24/2015 Patient Sequence Number: 1
-
-