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U.S. Department of Health and Human Services

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

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WIPRO GE HEALTHCARE PRIVATE LTD. MAC 5500 ELECTROCARDIOGRAPH Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 02/28/2015
Event Type  Injury  
Event Description

The customer reported that patient a arrived in the emergency room (er), had an ekg performed and was admitted to the critical care medical unit for observation at around 9:00 pm. Patient b arrived in the er and an ekg was performed at around 9:20 pm. Patient b's name was manually entered and the machine was switched off and back on again. At that time instead of re-entering patient b's name, patient a's name was chosen (in error) from the list of the ekg's needing to be completed on patient b. After ekg was done on patient b using patient a's name, this ekg was then uploaded into patient a's chart causing patient a to have an unnecessary cardiac cath based upon the reading that was suppose to be for patient b.

 
Manufacturer Narrative

Ge healthcare's investigation is ongoing. A follow-up report will be submitted when the investigation is completed.

 
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Brand NameMAC 5500
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 Key4795364
MDR Text Key5858385
Report Number9617277-2015-00013
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 04/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2015
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Event Location No Information
Date Manufacturer Received04/28/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2014
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: 05/26/2015 Patient Sequence Number: 1
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